NCIMS Hazard Guide Version 1 1 Revised 6-16-06

Hazards and
Controls Guide
For
Dairy Foods HACCP
Guidance for
Processors
Version 1.1
June 16, 2006
LIST OF REASONS FOR REVISONS TO THIS HAZARD
GUIDE
DATE REASON
03/21/2006 Editorial revisions made in page numbering and minor
heading numbering corrections.
06/16/2006 Title changed from “Dairy Foods HACCP Hazards and
Controls Guide” to “Hazards and Controls Guide Dairy
Foods HACCP”
Dairy Foods HACCP Standard and Controls Guide
Guidance for Processors
Table of Contents
I. Introduction
A. Status
1
B. Purpose 1
C. Comparison with the FDA Juice HACCP Regulations
1
D. Scope and Limitations 3
II. Terms and Definitions

4
III. Overview of the NCIMS HACCP Program

A. Voluntary Nature of the Program
6
B. Key Requirements of the NCIMS HACCP Program
6
IV. Prerequisite Programs

A. Required Prerequisite Programs
9
B. Acceptable Level of Protection by Prerequisite Programs
10
V. Hazard Analysis
A. Preparing for a Hazard Analysis – Five Preliminary Steps
11
B. Overview of the Hazard Analysis
11
VI. HACCP Decision Trees

A. NACMCF CCP Decision Tree #1
22
B. NACMCF CCP Decision Tree #2
23
C. IDFA Modified Decision Tree for HACCP
24
VII.Control Measures
A. HACCP Control Measures
25
i
B. Activities Not Considered to be HACCP Control Measures
25
VIII.Preparing for HACCP

A. Getting People Ready 26
B. HACCP Training and HACCP Resource Materials
26
IX. Hazards and Control Guide

A. Table 1 – Milk Plant Raw Materials 28
B. Table 2 – Milk Plant Processing Operations
30
X. References 59
i
I. Introduction
A. Status
This Hazards and Controls Guide represents the National Conference on

Interstate Milk Shipments (NCIMS) perspective on identifying and
evaluating potential hazards in milk and milk products and their control. It
is designed to assist processors in the development of Hazard Analysis
Critical Control Point (HACCP) systems to satisfy the requirements of the
NCIMS HACCP alternative to the traditional regulatory system for Grade A
dairy products that are regulated by the states under the NCIMS milk
safety system. The guide should also be useful to State Regulators who
are responsible for the evaluating the completeness of a plants hazard
analysis.
This Hazards and Controls Guide provides a framework for answering

some of the questions to be considered when conducting a hazard analysis
for the processing of milk and milk products.
This guide has been separated into two parts. The first part provides
background information that can be useful in understanding the basic food
safety concerns and goals to be addressed by the hazard analysis. The
second part of the hazard guide is an evaluation of specific potential
hazards associated with the processing of milk and milk products. It is
also divided into two major sections. The first section identifies many
potential food safety hazards associated with ingredients and packaging
materials. In the second section, a “unit operations” approach has been
used to identify food safety potential hazards which may be associated
with processing.
HACCP, as it relates to the NCIMS HACCP alternative, is a food safety

system whose design is based on practical experience and the scientific
understanding of the potential hazards associated with various types of
milk and milk products. References to the available scientific literature
can be found throughout this document. A list of references can be found
at the end of this guide.
B. Purpose
The purpose of this guidance is to assist you in the development of a

written HACCP program, as defined by the NCIMS Voluntary HACCP
System. You will find information in this guidance that will help you
identify hazards that may potentially occur in your products and help you
identify and use methods of controlling and preventing hazards. This
guidance is also intended to serve as a tool for Federal and State
regulatory officials in the evaluation of HACCP systems for dairy products.
To help understand some key aspects of the NCIMS Voluntary HACCP

System and plan how you will initiate your HACCP activities, we have
included information on some other important aspects of the Dairy HACCP
System.
C. Comparison with the FDA Juice HACCP Regulations

The following table is provided to dairy processors as a visual comparison
of the FDA Juice HACCP regulations and the NCIMS Voluntary Dairy
System.
Requirements FDA Juice HACCP NCIMS HACCP

Regulation 1/22/02 Large Business January 1, 2004
Implementation Dates: (>500 employees)
1/21/03 for Small

Business
(<500 employees)
1/20/04 for Very Small

Businesses
(<100 employees)
Prerequisite Program Yes Yes (PP)

Concept (GMP & SSOP)
Written Sanitation No Yes

Standard Operating
Procedure (SSOP) or
Required PP
Sanitation Monitoring & Yes Yes
Documentation (8 elements) (8 elements)
(SSOP) or Required PP
Perform Hazard Analysis Yes Yes
Written Hazard Analysis Yes Yes
Written HACCP Plan Yes Yes
Written Corrective Yes Yes

Action Plan Required:
HACCP Plan shall be Yes, Yes

signed and dated updated annually
Plan Revalidation Yes, at least once within Yes

Upon plan development 12 months of
implementation
Upon any change that Yes Yes
affect ingredients,
process, hazard analysis
or HACCP Plan
At least annually Yes Yes

Regulator Consumer No No
Complaint Record
Access
Maintain Customer Yes Yes
Complaint Summary
Monitoring & Corrective Within 7 days No minimum specified,
Requirements FDA Juice HACCP NCIMS HACCP
Action Records Review appropriate to records
being kept
Required Info on
Records Yes
Name & Location Yes (if more than 1 Yes
Date & Time location)
Yes
Monitor’s Initials or Yes, where appropriate Yes
Signature
ID of product & Code Yes, where appropriate Yes
Record Retention 1 year after the At least 1 year after the
production of the product date that such products
were prepared.
2 years for frozen, In the case of frozen,
preserved or shelf stable, preserved or shelf stable
or the shelf life of the products 2 years or the
product, whichever is shelf life of the product
greater. whichever is greater,
after the date that the
products were prepared
unless longer retention
time is required by other
regulations.
Industry Training Yes YES
(HACCP plan (Juice HACCP Core (NCIMS Dairy HACCP
developers, validators Curriculum) Core Curriculum)
and record reviewers) or
equivalent experience
Confidentiality Yes, within the limits of Not Addressed
FOIA
Copying Records Yes Not Addressed
Electronic Records Yes Yes
5-Log Pathogen Yes Mandatory CCP for
Reduction Performance pasteurization
Standard
LACF or One Step Exempt from the 5-log Hazards addressed as
Thermally Processed performance standard. critical factors by process
Shelf-Stable Juice or Other hazards must be authority are not
Juice Concentrates controlled. Shelf-stable required to be addressed
and concentrate in the HACCP Plan
processors must include a Summary Table
copy of their thermal
process in their written
hazard analysis. Must be
packaged in final form
under single roof or 5-log
needs to be done.
D. Scope and Limitations
This guide addresses development of a product flow diagram, description

of the product, hazard identification and hazard evaluation. It is not
intended to provide examples for development of prerequisite programs,
formation of the HACCP team, product distribution, risk analysis, etc.
Prior to conducting the hazard analysis, the HACCP team must complete
the following preliminary steps:
1. Develop a product description;
2. Develop and verify a process flow diagram
3. Describe the intended use and distribution parameters.
II. Terms and Definitions
A. AUDIT: An evaluation of the entire milk plant, receiving station or

transfer station facility and NCIMS HACCP System to ensure compliance with
the NCIMS HACCP System and other NCIMS regulatory requirements.
B. Centralized Deviation Log: A centralized log or file identifying data

detailing any deviation of critical limits and the corrective actions taken as
required in Appendix K of the Pasteurized Milk Ordinance (PMO).
C. Control: To manage the conditions of an operation to maintain

compliance with established criteria. The state where correct procedures are
being followed and criteria are being met.
D. Control Measure: Any action or activity that can be used to prevent,

eliminate or reduce a significant hazard that is managed at a Critical Control
Point.
E. Corrective Action: Procedures followed when a deviation occurs.
F. Critical Control Point (CCP): A step at which control can be applied

and is essential to prevent or eliminate a milk or milk product safety hazard or
reduce it to an acceptable level.
G. Critical Limit (CL): A maximum and/or minimum value to which a

biological, chemical, or physical parameter must be controlled at a CCP to
prevent, eliminate, or reduce to an acceptable level the occurrence of a milk
or milk product safety hazard.
H. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT,

RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT
REPORT identified with a double star (**). The marking of a CLE by a State
Rating Officer or FDA auditor, indicates a condition that constitutes a major
dysfunction likely to result in a potential compromise to milk or milk product
safety, or that violate NCIMS requirements regarding drug residue testing and
trace back or raw milk sources, whereby a listing may be denied or withdrawn.
I. DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:

1. Basic HACCP training; plus
2. An orientation to the requirements of the NCIMS HACCP Program
J. DEFICIENCY: An element inadequate or missing from the

requirements of the HACCP System or Appendix K of the PMO.
K. DEVIATION: A failure to meet a Critical Limit.

L. FOOD ALLERGENS: Are proteins in foods that are capable of inducing
an allergic reaction or response in some individuals. There is specific
consensus that the following foods account for more than 90% of all food
allergies: peanuts, soybeans, milk, eggs, fish, crustaceans, tree nuts, and
wheat.
M. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A

Systematic approach to the identification, evaluation, and control of
significant milk or milk product safety hazards.
N. HACCP PLAN: The written document, which is based upon the

principles of HACCP and delineates the procedures to be followed.
O. HACCP SYSTEM: The implemented HACCP Plant and Prerequisite

Program, including other applicable NCIMS requirements.
P. HACCP TEAM: The group of people who are responsible for

developing, implementing, and maintaining the HACCP system.
Q. HAZARD: A biological, chemical, or physical agent that is reasonable

likely to cause illness or injury in the absence of its control.
R. HAZARD ANALYSIS: The process of collecting and evaluating

information on hazards associated with the milk under consideration, to
decide which are reasonable likely to occur and must be addressed in the
HACCP Plan.
S. MONITOR: To conduct a planned sequence of observations or

measurements to assess that a CCP is under control or to assess the
conditions and practices of all required Prerequisite Programs.
T. NON-CONFORMITY: A failure to meet specified requirements of the

HACCP System as described in Appendix K of the PMO.
U. POTENTIAL HAZARD: Any hazard to be evaluated by the hazard

analysis.
V. PREREQUISITE PROGRAMS (PP’s): Procedures, including Good

Manufacturing Practices (GMP’s), which address operational conditions that
provide the foundation for the HACCP System. The required PP’s specified in
Appendix K of the PMO, are something called Sanitary Standard Operating
Procedures (SSOP’s) in other HACCP Systems.
W. VALIDATION: The element of verification focused on collecting and

evaluating scientific and technical information to determine whether the
HACCP Plan, when properly implemented, will effectively control the hazards.
X. VERIFICATION: Those activities, other than monitoring, that
determine the validity of the HACCP Plan and that the HACCP System is
operating according to the plan.
III.Overview of the NCIMS HACCP Program
The following section is a brief synopsis of Appendix K of the PMO detailing the
requirements of the NCIMS alternative HACCP program. For a complete
understanding of the NCIMS HACCP Alternative, please refer to the most recent
version of the PMO.
A. Voluntary Nature of the Program
The NCIMS HACCP Program alternative to the traditional inspection system is

a voluntary system as described in the applicable sections and Appendices of
the Pasteurized Milk Ordinance (PMO). No plant, receiving station or transfer
station may participate in the voluntary NCIMS HACCP Program unless the
Regulatory Agency responsible for the oversight of the facility agrees to
participate with the dairy plant(s), receiving station(s) and transfer station(s)
in the NCIMS HACCP Program. Both parties must provide written commitment
to each other that the necessary resources to support participation in the
NCIMS HACCP Program will be made available. Management responsible for
both the State and plant, receiving station or transfer station must be willing
to provide the resources needed to develop and implement a successful
HACCP System.
B. Key Requirements of the NCIMS HACCP Program
1. Specialized Training in NCIMS HACCP Principles Required
HACCP training for industry and regulatory personnel will be based on the
current “Hazard Analysis and Critical Control Point Principles and
Application Guidelines” of NACMCF, the current FDA HACCP
recommendations, and the regulatory requirements of Appendix K and
related Sections of the PMO.
Regulatory Agency personnel responsible for the evaluation, licensing and

regulatory audits of facilities using the NCIMS HACCP Program will have
equivalent training to the training required to perform traditional NCIMS
functions. They shall also have specialized training in conducting HACCP
System audits.
Industry, State and Federal regulatory and listing personnel should be

trained together.
a. HACCP Training
♦ Core Curriculum: The Dairy HACCP Core curriculum consists of:

1. Basic HACCP training; plus
2. An orientation to the requirements of the NCIMS HACCP
Program.
Basic HACCP training consists of instruction in the application of the
NACMCF Principles of HACCP to Food Safety. This training includes
practical exercises in conducting a hazard analysis and evaluating
potential hazards; in writing a HACCP Plan, and in the validation of the
plan. It should be taught by experienced instructors.
The orientation component ideally is coupled with the basic HACCP

training, but can be taught separately. The content of the orientation will
be conducted under the guidance of the NCIMS. It is intended to
familiarize industry and regulatory personnel with specific dairy HACCP
concerns and the regulatory requirements under the NCIMS HACCP
Program. It is to be taught by instructors experienced in the application of
HACCP under the NCIMS HACCP Program.
The industry individual(s) performing the functions listed in Part 2 of this

Section shall have successfully completed appropriate training in the
application of HACCP principles to milk and milk product processing at
least equivalent to that received under the Dairy HACCP Core Curriculum.
Alternatively, job experience may qualify an individual to perform these
functions if the experience has provided knowledge at least equivalent to
that provided through the standardized curriculum.
• Industry Personnel: Only industry individuals who have met the

requirements of Part 1 of Appendix K Section III of the Pasteurized Milk
Ordinance (PMO) - Training and Standardization, shall be responsible
for the following functions.
a. Developing the hazard analysis, including delineating control

measures as required.
b. Developing a HACCP Plan that is appropriate for the specific milk
plant, receiving station or transfer station, in order to meet these
requirements.
c. Validating and modifying the HACCP Plan in accordance with the
corrective action procedures and the validation activities as
specified; and
d. Performing required HACCP Plan records reviews.
• Regulatory Personnel: Regulatory personnel performing HACCP audits

shall have successfully completed the appropriate training in the
application of HACCP principles for milk and milk product processing at
least equivalent to that received under the Dairy HACCP Core
Curriculum.
2. Recordkeeping and Electronic Records
a. Required Records: It is essential that plants, receiving stations and

transfer stations use consistent terminology to identify each piece of
equipment, record, document, or other program throughout their
written HACCP System. A milk plant, receiving station or transfer
station shall maintain the following records documenting the milk
plant, receiving station or transfer station’s HACCP System:
1. A brief description of the monitoring and correction records shall

be written documenting the ongoing application of the prerequisite
program.
2. A hazard analysis shall be written
3. The written HACCP Plan;
4. Required HACCP documents and forms specified in a.1) through 3)

of this Section shall be dated or identified with a version number.
Each page shall be marked with a new date or version number
whenever that page is updated.
5. A Table of Contents and centralized list of the HACCP program

records, by title, documenting the ongoing application of the
HACCP System shall be maintained and provided for review.
6. A document change log shall be kept.
7. Records documenting the ongoing application of the HACCP Plan

that include:
1. Monitoring of Critical Control Points and their Critical Limits,

including the recording of actual times, temperatures, or other
measurements, as prescribed in the plant’s receiving station’s
or transfer station’s HACCP Plan;
a. Corrective actions, including all actions taken in response

to a deviation.
b. A centralized deviation log is required; and
c. Plan validation dates.
d. Records documenting verification and validation of the

HACCP System, including the HACCP Plan, hazard analysis
and PP’s.
2. General Requirements: Records required include:
a. The identity and location of the milk plant,

receiving station or transfer station;
b. The date and time of the activity that the

record reflects;
c. The signature or initials of the person(s)

performing the operation or creating the record; and
d. Where appropriate, the identity of the product

and the production code, if any. Processing and other
information shall be entered on records at the time that it
is observed. The records shall contain the actual values
and observations obtained during monitoring.
3. Documentation:
a. The records in paragraphs a.1) through 3) of

this Section shall be signed and dated by the most
responsible individual onsite at the milk plant, receiving
station or transfer station. This signature shall signify that
these records have been accepted by the firm.
b. The records in paragraphs a.1) through 3) of

this Section shall be signed and dated:
1. Upon initial acceptance;

2. Upon any modification; and
3. Upon verification and validation in accordance
with the requirements cited above
4. Record Retention:
a. All records, required by this section, shall be retained at
the milk plant, receiving station or transfer station for
perishable or refrigerated products, for at least one (1)
year after the date that such products were prepared,
and in the case of frozen, preserved, or shelf-stable
products, for two (2) years after the date that the
products were prepared or the shelf-life of the product,
whichever is greater, unless longer retention time is
required by other regulations.
b. Records that relate to the adequacy of equipment or
processes used, such as commissioning or process
validation records, including the results of scientific
studies and evaluations, shall be retained at the milk
plant, receiving station or transfer station facility for at
least two (2) years after the date that the milk plant,
receiving station or transfer station last used such
equipment or process.
c. Off-site storage of processing records is permitted after

six (6) months following the date that the monitoring
occurred, if such records can be retrieved and provided
on-site within twenty-four (24) hours of a requires for
official review. Electronic records are considered to be
on-site if they are accessible from an on-site location.
IV. Prerequisite Programs

The following required Prerequisite Programs shall have a brief written description
or checklist that the prerequisite programs can be audited against to ensure
compliance. Prerequisite Programs shall include procedures that can be
monitored, records that specify what is monitored, and how often it will be
monitored.
A. Required Prerequisite Programs
1. Safety of the water that comes into

contact with milk or milk products or product contact surfaces, including
steam and ice.
2. Condition and cleanliness of

equipment product contact surface.
3. Prevention of cross-contamination
from unsanitary objects and or practices to milk or milk products or
product contact surfaces, packaging material and other food contact
surfaces, including utensils, gloves, outer garments, etc., and from raw
product to processed product;
4. Maintenance of hand washing,

hand sanitizing and toilet facilities.
5. Protection of milk or milk product,

packaging material, and product contact surfaces from adulteration with
lubricants, fuel, pesticides, cleaning compounds, sanitizing agents,
condensate and other chemical, physical and biological contaminants;
6. Proper labeling, storage and use of

toxic compounds;
7. Control of employee health

conditions, including employee exposure to high risk situations, that could
result in the microbiological contamination of milk or milk products,
package materials, and product contact surfaces; and
8. Exclusion of pests.
9. Required Programs (PP’s) used as

justification in the Hazard Analysis
In addition to the required PP’s specified above, any other prerequisite

programs that are being relied upon in the Hazard Analysis to reduce the
likelihood of occurrence of hazards such that they are not reasonably likely to
occur must also be monitored, audited, and documented as required PP’s.
B. Acceptable level of protection by prerequisite programs
Prior to the implementation of a HACCP Plan, there is a requirement for dairy

plants, receiving stations and transfer stations to develop, document and
implement written PP’s. PP’s provide the basic environment and operating
conditions that are necessary for the production of safe, wholesome food.
Many of the conditions and practices are specified in Federal and State
regulations and guidelines.
HACCP is not a stand-alone program, but is part of a larger control system.
PP’s are the universal procedures used to control the conditions of the plant
environment that contribute to the overall safety of the product. They
represent the sum of programs, practices and procedures that must be
applied to produce and distribute safe products in a clean, sanitary
environment. They differ from CCP’s in that they are basic sanitation
programs that reduce the potential occurrence of a milk or milk product safety
hazard. Frequently, both HACCP Plan CCP’s and PP’s control measures are
necessary to control a food safety hazard.
HACCP may be implemented only in a facility that is constructed and operated
to provide a sanitary environment. Milk plant, receiving station or transfer
station premises, building construction, maintenance, and housekeeping shall
be maintained in a manner sufficient to provide such an environment. These
factors shall be controlled by effective plant, receiving station or transfer
station programs or by PP’s, as the plant, receiving station or transfer station
chooses.
PPs are the universal procedures used to control the condition of the plant
environment that contribute to the overall safety of the product. They
represent the sum of programs, practices and procedures that must be
applied to produce and distribute safe products in a clean, sanitary
environment. They differ from CCP's in that they are basic sanitation
programs that reduce the potential occurrence of a food safety hazard.
Frequently, both HACCP Plan CCP’s and PP's control measures are necessary
to control a food safety hazard. The exact set of PP’s will vary since their
application is product and process specific. The existence and effectiveness
of PP’s should be assessed during the design and implementation of each
HACCP Plan. PP’s should be documented and regularly audited. An audit
review consists of verifying that the company has a program implemented
that indicates how the company monitors and controls each of the PP’s. PP’s
are established and managed separately from the HACCP Plan.
V. Hazard Analysis
A. Preparing for a Hazard Analysis – Five Preliminary Steps
Although not required by the NCIMS HACCP alternative, the 5 preliminary

steps of HACCP as outlined by the National Advisory Committee of
Microbiological Criteria for Foods (NACMCF) will help you in conducting
your hazard analysis and developing your HACCP plan, and will prove
valuable for other HACCP functions. The steps you should follow are:
1. Step 1 Assemble a HACCP Team.
2. Step 2 Describe the food and its distribution.
3. Step 3 Identify the intended use and consumers of the food.
4. Step 4 Develop a flow diagram that describes the process.
5. Step 5 Verify the accuracy of the flow diagram.
For more information, see the NACMCF publication “Hazard Analysis and
Critical Control Point Principles and Application Guidelines,” Journal of Food
Protection, Vol. 61, No. 9, pp. 1246-1259 (1998), (the “HACCP Principles
and Guidelines” publication).
B. Overview of the Hazard Analysis
1. Description
The dairy hazard analysis is a process of collecting and evaluating

information on hazards associated with dairy products, to determine which
hazards are reasonably likely to occur and must be addressed in a HACCP
Plan. Under the dairy HACCP alternative, you are required to produce, for
each type of Grade A dairy product you process, a written hazard analysis
to determine whether there are food hazards that are reasonably likely to
occur and to identify measures that you can apply to control those
hazards. The dairy alternative requires a written hazard analysis for each
type of dairy product unless different types of dairy products have
identical hazards and control measures that can be combined into one
hazard analysis.
Do not conduct the hazard analysis until the prerequisite programs have
been developed, implemented and documented. This Hazard and Controls
Guide may be used to aid in constructing and evaluating those
prerequisite programs to be considered in the hazard analysis. The hazard
analysis may point out the need for additional prerequisites.
2. Relevance to HACCP Plan and Prerequisite Programs
All processors that decide to participate in the NCIMS HACCP alternative

are required to prepare a written hazard analysis. If you determine that
any hazard is “reasonably likely to occur” in a particular product, you must
control that hazard in the product by applying control measures as part of
a properly designed and implemented HACCP plan, except that some
hazards can be managed under your PP’s. If you determine that no
hazards are “reasonably likely to occur,” you are not required to develop a
HACCP Plan, but you must establish and implement PP’s. Your PP
monitoring and correction records and your hazard analysis are still
subject to the record keeping and official record review requirements.
Under the NCIMS HACCP system, pasteurization must always be managed
as a CCP. Useful examples of both batch and continuous flow
pasteurization can be found in the PMO, Appendix H.
3. Developed by HACCP-trained Employee or Consultant

Your hazard analysis must be developed by an appropriately trained
individual (or individuals) based on the Core Curriculum or comparable
experience, as specified in the NCIMS HACCP Alternative. This person may
be your employee or a hired outside expert.
4. Basic Steps of the Hazard Analysis
a. Identify All Potential Hazards
1. Biological Hazards
a. Bacteria
The vegetative pathogens of concern associated with milk

and processed milk products are Salmonella spp., L.
monocytogenes, enterohemorrhagic E. coli, and
Campylobacter jejuni. Spore forming bacteria of concern
includeC. botulinum, and B. cereus. All these organisms
occur in raw milk and most have been associated with
illness outbreaks in milk products. These pathogens in milk
have the potential for causing severe adverse health effects
with the very young, the elderly, and immune-compromised
individuals being at the greatest risk. While enteric
pathogens have been implicated as the cause of most food-
borne illness outbreaks associated with milk products, these
are not the only organisms that could occur in milk.
The potential of hazards associated with toxin-producing

bacteria and spore-formers should be evaluated in
processing circumstances where unusual conditions exist.
In the case of toxin-producers such as S. aureus and B.
cereus, these organisms must multiply to significant levels
to produce sufficient toxin to be a public health risk. This is
a concern when levels reach above 106 or greater.
However, the rule of thumb for temperature control of a
food is that controls should be implemented when
conditions indicate that there might be a 3- log increase in
S. aureus or B. cereus.1 The hazard of C. botulinum
associated with aseptically processed milk products is
effectively managed in aseptic milk plants though the filed
process that is required under 21 CFR 108 and 113.
Validation of processes requiring measurement of the

production of enterotoxin is expensive and difficult.
However, during the 2005 NCIMS, the NCIMS Scientific
Committee reviewed and accepted some useful guidelines
that have been actually incorporated into the PMO.
These guidelines, below, should be construed generally as

"safe harbor" when conducting hazard analyses and
validating control measures:
• Balance tanks or surge tanks with an average retention

time of one hour or less may be safely operated for up to
24 hours regardless of product temperature in both
pasteurized and unpasteurized dairy products.
• Pasteurized milk and milk products to be condensed
and/or dried, can be maintained at a temperature of 10C
(50F) or less until pasteurized.
• Tanks used to hold pasteurized milk and milk products to
be condensed or dried that are operated above 10C
(50F) must be emptied, cleaned and sanitized after each
6 hours or less.
• All whey and whey products for condensing and/or
drying can be safely maintained at a temperature of 7C
(45F) or less; or 57C (135F) or greater.
• Tanks used to hold whey and whey products between 7C
(45F) and 57C (135F), must be emptied, cleaned and
sanitized after each 4 hours or less. Except that, acid-
type whey with a titratable acidity of 0.40% or above, or
a pH of 4.6 or below, can be safely held at any
temperature.
• Crystallization of condensed whey and whey products
may be accomplished without the formation of toxins if
the whey or whey products being crystallized are cooled
to 10C (50F) or less; within 72 hours of condensing
including the filling and emptying time, unless filling
occurs above 57C (135F), in which case, the 72 hour
time period begins when the cooling is started.
Other properly validated times and temperatures that have

been recognized by FDA and that are approved by the State
Regulatory Agency may also be considered to be safe.
This guidance does not cover the hazards associated with

the formation of C. botulinum toxin in milk products that are
classified as shelf-stable acidified foods or low acid canned
foods.
Bad U.S. Food & Drug Administration

Bug Center for Food Safety & Applied Nutrition
Book Foodbourne Pathogenic Microorganisms
And Natural Toxins Handbook
Factors Affecting the Growth of Some Foodbourne Pathogens
Organism Growth Temperature Growth pH Growth aw

(oC)
Salmonella spp. 6.5 - 47 4.5 - ? > 0.95 (a)
Clostridium botulium
A&B 10 – 50 4.7 – 9 > 0.93
Nonproteolytic B 5-? (b) NR (c)
E 3.3 – 15 - 30 (b) > 0.965
F 4-? (b) NR (c)
Staphylococcus aureus 7 – 45 4.2 – 9.3 > 0.86
Campylobacter jejuni 25 – 42 5.5 – 8 NR
Yersinia enterocolitica 1 – 44 4.4 – 9 NR
Yersinia 5 – 43 (b) NR
pseudotuberculosis
Listeria monocytogenes 0 – 45 4.4 – 9.4 > 0.92 (d)
Vibrio cholerae O1 8 – 42 6 – 9.6 > 0.95
Vibrio cholerae non-O1 (b) (b) (b)
Vibrio parahaemolyticus 12.8 – 40 5 – 9.6 > 0.94
Clostridium perfringens 10 – 52 5.5 – 8 > 0.93
Bacillus cereus 10 – 49 4.9 – 9.3 > 0.95
Escherichia coli 2.5 – 45 4.6 – 9.5 > 0.935
Shigella spp. > 8 - < 45 ? – 9 – 11 NR
Streptococcus pyogenes >10 - < 45 4.8 - < 9.2 NR
(a) For a genus as large as Salmonella, the aw lower limit for species growth may vary,
e.g., S. Newport = 0.941, S. typhimurium = 0.945.
(b) The value, though unreported, is probably close to other species of the genus.
(c) NR denotes that no reported value could be found, but for most vegetative cells, an aw
of > 0.95 would be expected.
(d) Updated values from the 1996 ICMSF Microorganisms in Foods 5: Characteristics of
Microbiological Pathogens.
Most values taken from Microbial Survival in the Environment, E. Mitscherlich and E.H.
Marth (eds.), Springer-Verlag, Berlin and Heidelberg, 1984. This is a valuable,
recommended reference. [ISBN 3-540-13726-2 Springer-Verlag, Berlin, New York, Tokyo]
[ISBN 0-387-13726-2 Springer-Verlag, Heidelberg, Berlin, Tokyo].
b. Viruses
Contamination of food by viruses, if it occurs, is most likely

to be caused by contaminated water or an ill individual.2
Contamination of milk by viruses is not likely to occur in a
processing facility that controls employee health and
hygiene conditions that could result in the microbiological
contamination of food, food packaging materials, and food
contact surfaces under its Prerequisite Programs (PP’s).
2. Chemical Hazards
a. Undeclared food allergens in dairy products due to cross-

contact from shared processing equipment.
Allergens, or proteins derived from allergenic foods, may be

present in foods as the result of cross-contact during
processing and handling. The term "cross-contact" describes
the inadvertent introduction of an allergen into a product
that would not intentionally contain that allergen as an
ingredient.
Eight major foods or food groups--milk, eggs, fish,

crustacean shellfish, tree nuts, peanuts, wheat, and
soybeans-- account for 90 percent of food allergies. In
addition, some food ingredients can cause food sensitivities
in certain individuals. Certain ingredients which cause food
sensitivities, such as sulfites, Yellow #5 (21 CFR 74.1705),
and aspartame (21 CFR 172.804), require special labeling
statements to alert consumers to their presence.
Cross-contact is generally the result of environmental

exposure during processing or handling, which may occur
when multiple foods are produced in the same facility or on
the same processing line, through poor re-work
management or ineffective cleaning. Cross-contact of foods
with allergens has been shown to lead to allergic reactions
in consumers on numerous occasions (Gern et al., 1991;
Jones et al., 1992; Yunginger et al., 1983). Most cross-
contact can be avoided by controlling the production
environment.
Procedures to ensure that these ingredients of concern are

properly identified on the label should be a part of the
HACCP system. Dairy plants should implement label control
as part of their allergen control program. This label control
program includes verification that the label reflects the
current formulation and the correct ingredient statement.
Prerequisite Programs addressing product changeover(s),
scheduling, and sanitation practices normally assist in
managing products containing allergens or substances that
cause food sensitivities.
The following references may prove useful in the area of allergen

control.
1. This section of the FDA's Compliance Policy Guide Deals with
Food Allergens
http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-
250.htm
2. FDA Allergy Inspection Guide
http://www.fda.gov/ora/inspect_ref/igs/Allergy_Inspection_Guide.
htm
3. Food Allergen Labeling and Consumer Protection Act of 2004
http://www.cfsan.fda.gov/~dms/alrgact.html
4. IDFA, IDFA’s Dairy HACCP Plant Manual
5. Deibel, Kurt, Tom Trautman, Tom DeBoom, William H.
Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard.
1997. A Comprehensive Approach to Reducing the Risk of
Allergens in Food. Journal of Food Protection. Vol. 60, No. 4:
436-441.
While not within the scope of the NCIMS Dairy product
safety HACCP system, it is necessary for milk plants that
manufacture juice or other food products using common
equipment for both milk or milk products and these
other foods to take precautions to prevent
contamination of these foods with milk allergens.
b. Allergens and substances that cause food sensitivities

added to dairy products as ingredients.
Allergens are not present in all products. Scheduling

product changeovers and run matrices, labeling, and
sanitation practices are suggested prerequisite programs
used to manage products containing allergens. Some
products (e.g., flavored bottled waters, cultured products of
dairy-based beverages with juice) can contain ingredients
such as soy protein or preservatives, such as sulfites, that
can cause allergic or food intolerance reactions in sensitive
individuals. The presence of any ingredient must be
declared on the label in accordance with the food labeling
regulations in 21 CFR Part 101. Programs to ensure that the
proper labels are used should be part of the PP within the
HACCP Program. Ingredient controls should be implemented
for the big eight allergens and ingredients which cause food
sensitivities.
c. Cleaning and Sanitizing Chemical Residues
Cleaning chemical and sanitizers are used widely in dairy

plants. The proper use of cleaning and sanitizing
compounds renders the risk of contamination a hazard not
likely to occur when managed by a properly implemented
prerequisite program. Numerous U.S. government
regulatory programs address aspects of cleaning and / or
sanitizer usage. Cleaning and sanitizing chemicals should
be used in accordance with the manufacturer’s instructions
and recommendations. These chemicals must be used at
proper concentrations for effective use and in the case of
sanitizers for their no-rinse properties. Proper cautions must
be taken to fully drain all processing equipment of cleaners
and sanitizers prior to use.
During processing, pipelines and equipment used to contain

or conduct milk products shall be effectively separated from
tanks or circuits containing cleaning and / or sanitizing
solutions. Proper guidelines for proper chemical and
product separation can be found in the PMO section 15p (B).
d. Agricultural Chemical Residues (Chemicals used in animal

and health and crop production).
Pesticides are used widely to treat (e.g., for insect control)

fruits, vegetables, grains and other foods, and may be
present in small amounts as residues on these foods.
Numerous U.S. government regulatory programs address
aspects of pesticide usage. Experience in the U.S. has
demonstrated that domestically grown fruits and vegetables
have a high level of compliance with U.S. pesticide tolerance
regulations and that the occurrence of unlawful pesticide
residues in food is likely to be infrequent and unlikely to
have a severe public health impact. Based on current
regulatory programs and FDA market basket surveys,
pesticide residues do not present food hazard likely to occur
in dairy products and do not need to be addressed in the
hazard analysis.
Animal drug residues are present at low levels in a very low

percentage of raw milk received at milk plants in the U.S.
These residues are regulated under PMO Appendix N for
both the traditional and the HACCP alternative systems.
Information in recent National Milk Drug Residue Database

Reports showed that less than one-tenth of 1 percent of milk
samples from bulk milk pick-up tankers (the form in which
raw milk is received at milk plants) tested positive for drug
residues last year. The report contains data on samples and
tests conducted during fiscal year 2003 (October 1, 2002 –
September 30, 2003). During this period, 4,382,974 total
samples were analyzed for drug resides. Samples included
bulk milk pickup tankers (78 percent, or 3,571,834
samples), producer milk (18 percent), pasteurized products
(2 percent), and other (2 percent). Fifty-three methods
were used to analyze these samples for residues. The most
recent National Drug Residue data base should be consulted
to obtain the latest information on drug residues in milk.
e. Over Fortification of Pasteurized Fluid Milk with Vitamin A

and D.
Jacobus et al3 reported that “Vitamin D has been added to

milk in the United States since the 1930’s.” In an article
published in the New England Journal of Medicine, Holick3
discusses vitamin D intoxication caused by drinking milk
fortified with excess vitamin D over an extended period of
time that led to questions about the level of vitamin D in
milk. Jacobus3 also reported an analysis of the amount of
vitamin D, in milk from a dairy implicated in an intoxication
that revealed concentrations that ranged from undetectable
to as high as 232,565 IU per quart. Vitamin A can also be
toxic if consumed at extremely high levels (see PMO
Appendix O).
f. Mycotoxins
In many parts of the country mycotoxins are not normally a

potential hazard. However in those milk plants that receive
milk from an area that has a history of aflatoxin
contaminated feed or if weather conditions are appropriate
for mycotoxin growth, it should be considered.
3. Physical Hazards
Foreign material includes such things as metal, glass, or plastic

fragments or any other material that might cause injury or present a
choking hazard. Consideration of potential hazards associated with
metal fragments should be a part of the hazard analysis when metal
fatigue, wear of metal parts, or metal to metal contact can occur in
processing equipment. See FDA compliance policy guide chapter 5 sub
555 section 555.425 (Adulteration involving hard or sharp objects
March 1999)
VI. The HACCP Hazard Decision Process
a. Evaluate All Potential Hazards

Evaluate each of the potential hazards (from Step 1) by assessing
the likelihood of occurrence and the severity of health
consequences associated with the potential hazard. For instance:
Although potential hazards that may be introduced into food

through pests in your facility may be of low to moderate severity,
they are unlikely to occur if your facility carries out an effective
pest control program as part of its required PP’s.
b. Determine If Potential Hazards Will Require Controls in Your HACCP

Plan
c. Potential Hazards “Reasonably Likely to Occur”
If a potential hazard has a severe, acute public health impact, that

hazard is reasonably likely to occur, even at an extremely low
frequency of occurrence, and thus should be identified as a hazard
that is reasonably likely to occur (e.g., pathogenic microorganisms
or injury caused by ingestion of metal fragments). Milk containing
enteric microbial pathogens such as E. coli O157:H7 and various
Salmonella species have caused serious food borne illness
outbreaks.
Those hazards which are determined to be “reasonably likely to

occur” in the hazard analysis must be controlled by a CCP.
d. Potential Hazards “Not Reasonably Likely to Occur”
The determination that a potential hazard is “not reasonably likely

to occur” is made in the hazard analysis and takes into account
existing PP’s, GMP’s, etc. This determination is based on the
unique conditions at the plant making the hazard analysis.
If conditions in the plant change, the hazard needs to be

reevaluated. If the hazard analysis is performed correctly, based
on the individual conditions at the milk plant and if the HACCP
system is validated at least once each year as required, these
types of determinations will be more likely to be sustained during
regulatory and listing audits of the plants HACCP system.
e. Hazards Related to Facility Sanitation
When the hazard analysis identifies hazards classified as hazards

“not reasonably likely to occur,” they should be managed by the
PP’s or GMP’s.
HACCP may be implemented only in a facility that is constructed

and operated to provide a sanitary environment. Milk plant
premises, building construction, maintenance and housekeeping
shall be maintained in a manner sufficient to provide such an
environment. These factors shall be controlled by effective plant,
receiving station or transfer station programs or by PP’s, as plant,
receiving station or transfer station chooses.
f. Controls for Potential Hazards Arising from Food Contact Surfaces

Hazards can occur in milk due to unsanitary food contact surfaces
that can contaminate milk with pathogens or with residual
allergens from product processed on the equipment in prior runs
that can cause allergic reactions in sensitive individuals. Hazards
that arise from unsanitary food contact surfaces have the potential
to affect the safety of a milk product because they arise from
points within the process and not from general conditions within
the facility. Control of these hazards may be accomplished by the
use of Prerequisite Programs. For example, an appropriate PP could
be to establish a procedure for cleaning equipment with a cleaning
solution, e.g., a pre-rinse followed by a caustic wash followed by a
rinse. The procedure could include maintaining a log of which
foods, e.g., juice, eggnog, soy drinks, were processed on the
equipment, the sequence in which the foods were processed, and
how/when the equipment was cleaned. The operator could check
that log prior to starting any production run for milk. The
procedure could provide that the equipment would not be used for
milk until the prescribed cleaning procedure was carried out,
recorded in the log, and the equipment was visually checked for
cleanliness.
g. Identify Control Measures and CCPs.
h. HACCP Control Measures
Under the voluntary HACCP alternative, you are required to

implement HACCP control measures if you determine in your
hazard analysis that a food hazard is reasonably likely to occur in
your dairy product.
Examples of HACCP control measures used in the processing of
dairy products include measures carried out at CCPs specified in a
HACCP plan such as pasteurization of dairy products for the
elimination or reduce to an acceptable level of micobiological
pathogens.
1. Control Measures for Biological Hazards
The pasteurization of milk is the most effective single control

measure for protecting consumers from pathogenic
microorganisms. Therefore, the pasteurization process is a
required control measure for pathogens.
2. Control Measures for Chemical Hazards
When a chemical hazard is identified that is reasonably likely to

occur in milk, a control measure needs to be established in the
HACCP plan for that hazard. Chemical hazards that are most
commonly identified in the hazard analysis include equipment
cleaning and sanitizing chemicals, animal drug residues and over
addition of food grade vitamins. The likelihood of occurrence of
each of these hazards will vary according to the plant and its
procedures. If control measures are warranted for any of these
hazards they are addressed below.
a. Equipment Cleaning and sanitizing chemicals – Control
of his hazard, if deemed “reasonably likely to occur”
must address establishing CCPs at all product storage
tanks, all processing equipment that is not self-
draining, and at each CIP system. In the case of
product storage tanks and non-draining processing
equipment, the critical limit will be presence of no
cleaning or sanitizing chemicals prior to use. The
monitoring record for this CCP can be manual check
logs, electronic sensor logs, etc. For each CIP system,
the critical limits will be the measurements used for
controlling cleaning and sanitizing chemical
concentration. The monitoring record will usually be a
graph or computer-generated CIP monitoring
document.
b. Animal drug residues – This chemical hazard, if
deemed “reasonably likely to occur”, will be controlled
through a CCP at raw milk receiving with the critical
limit being the no detectable animal drug residue
present in the raw milk. The monitoring record for this
CCP will be the animal drug residue testing record
maintained by the on-site industry laboratory.
c. Food-grade vitamins – This chemical hazard, if deemed
“reasonably likely to occur” will be controlled by a CCP
at the point of injection or addition into the milk
stream. The critical limit will be the FDA-established
levels of vitamin A and D for fluid drinking milk and
possible the actual measurement of the vitamin
addition via pump speed or volume per batch.
Monitoring will be based on manual logs capturing the
actual measurements of vitamin addition (pump speed
recorded at least daily, volume of addition per batch,
etc.), as well as the theoretical versus actual vitamin
reconciliation records required by the PMO.
3. Control Measures for Physical Hazards
The necessity for control measures for any potential physical

hazard is dependent upon a conclusion from the hazard analysis
that the specific hazard is reasonably likely to occur in the milk
product. FDA has issued a Compliance Policy Guide (CPG Section
555.425) describing when hard or sharp foreign objects in food,
such as glass or metal fragments, could pose a health hazard. If it
is reasonably likely that the milk product may become
contaminated with hard or sharp foreign objects that meet the
criteria in this CPG, you should regard the object as a potential
hazard in the milk.
i. Other Interventions
The hazard analysis may identify hazards that can be eliminated or
reduced to hazards not likely to occur if adequate changes are
made in the plant facility or its environment, by equipment
replacement or modifications, or adjustments to operating
procedures. Engineering the hazard out of the process is usually
the best alternative to eliminate or reduce the likelihood of
occurrence.
VII. HACCP Decision Trees
CCP decision trees have been developed to assist HACCP developers in determining
CCP’s in the facilities process. Three example CCP decision trees are in the following
pages of this hazard guide. Two decision trees are prepared by the NACMCF and the
third has been developed by IDFA. The HACCP team may use decision trees to
evaluate each hazard to determine if each hazard can be prevented, eliminated or
reduced to an acceptable level.
A common problem with using existing HACCP decision trees is trying to apply the
questions prior to completion of the hazard analysis. Decision trees sometimes also
show results which common sense says is incorrect. Thus, decision trees should be
used with caution.
Decision trees are only tools that can be used to assist in determining CCP’s. Milk
plants are not required to use them to determine CCP’s. Many HACCP teams
determine CCP’s based on the knowledge and experience of their process and
existing plant control measures.
NACMCF CCP Decision Tree #1
Do preventive measures exist at this step or subsequent steps for the identified
hazard?
Modify step,
Yes No process or
product
Does this step eliminate or Yes

reduce the likely occurrence
of a hazard to an acceptable
level?
Is control at this step
necessary for safety?
No
Could contamination with identified

hazards occur in excess of acceptable
levels or could these increase to
unacceptable levels?
Yes
Yes No No
Will a subsequent step eliminate

identified hazards or reduce the likely
occurrence to an acceptable level?
No
CRITICAL CONTROL STOP NOT A CRITICAL

POINT CONTROL POINT
NACMCF CCP Decision Tree #2
Does this step involve a hazard of sufficient likelihood of occurrence and severity
to warrant it’s control?
Yes No
Does a control measure for

Modify the step,
the hazard exist at this
process or product
step?
Yes No Yes
Is control at this step necessary for

safety?
No
Is control at this step

necessary to prevent,
eliminate or reduce the
risk of the hazard to
consumers?
Yes
CRITICAL CONTROL STOP NOT A CRITICAL

POINT CONTROL POINT
IDFA CCP Decision Tree #3
Q1. Is the hazard
identified at this step of
sufficient likelihood of
occurrence to warrant its Not a CCP
control?
Q3. Does the control measure for the

Q2. Identify the Prerequisite
hazard exist at this step?
Program or procedure that manages
the hazard to ensure that control at
this step is not necessary.
Modify this step, process, or

Is control at this step product to eliminate this hazard
necessary? or provide a control measure,
then revisit the hazard analysis
Proceed to the step where a control

measure exists for this hazard and begin
at Q4.
Q4. Does this step prevent, reduce or

eliminate the likely occurrence of the CCP
hazard to an acceptable level?
Q5. Could contamination with the identified hazard occur in excess of

the safe or acceptable level or could it increase to an unacceptable level?
This step is
Q6. Will a subsequent step eliminate the identified not a CCP
hazard or reduce its likely occurrence to a safe level?
Subsequent CCP (Control at this step is necessary to prevent or

step is the reduce the risk of a hazard but may not eliminate it.)
CCP.
VII. Control Measures
A. HACCP Control Measures
Under the voluntary HACCP alternative, you are not required to

implement control measures if you determine in your hazard analysis
that a food hazard is not reasonably likely to occur in your dairy
product.
Examples of HACCP control measures used in the processing of dairy

products include measures carried out at CCP’s specified in a HACCP
plan such as pasteurization of dairy products for the elimination or
reduction to an acceptable level of microbiological pathogens.
B. Activities Not Considered to be HACCP Control Measures
1. Other Regulatory Requirements that are not a part of the NCIMS

HACCP System
a. Raw Milk Supply Source;

b. Labeling Compliance;
c. Adulteration;
d. Licensing Requirements;
e. Drug Residue and Trace Back Requirements;
f. Regulatory Samples in Compliance;
g. Approved Laboratory Utilized for the Regulatory Tests; and
h. Pasteurization Equipment Design and Installation
2. GMPs (note building and facilities)
Some activities that firms may undertake in processing milk and milk
products and in related functions are not HACCP control measures.
These include Good Agricultural Practices (GAPs) and Current Good
Manufacturing Practices (cGMP).
3. GAPs
GAPs are measures voluntarily undertaken by these parties which are

not HACCP controls. However, if a hazard originating from the
agricultural environment is determined to be reasonably likely to occur
in your incoming dairy products, it must be identified in your hazard
analysis and controlled through your HACCP plan. If control of such a
hazard involves actions that will be carried out by your supplier, your
control measure could be based upon a supplier guarantee to this
effect implemented as part of your HACCP plan.
However, we encourage you to work with your suppliers to evaluate

and modify agricultural practices in accordance with FDA’s GAPs
guidance document.
4. CGMPs
As noted above, dairy processors are still required to comply with the
CGMPs requirements of 21 CFR Part 110. One common misconception
about HACCP is that some hazards that are reasonably likely to occur
can be controlled under a firm’s CGMP programs under 21 CFR Part
110. Because programs to comply with 21 CFR Part 110 are general in
nature and are not designed to control specific hazards, they are not
HACCP control measures. Therefore, you cannot use CGMP programs
to control a specific hazard that you have concluded is reasonably
likely to occur in your hazard analysis. You must use HACCP controls
for any such hazard.
VIII. Preparing for HACCP
A. Getting People Ready
Successful implementation of HACCP requires trained people who

cooperate from the preliminary stages to the implementation and
ongoing operation of the HACCP system. We strongly recommend that
you begin with Step 1 of NACMCF’s 5 preliminary steps of HACCP, by
assembling a HACCP team that includes plant level and corporate level
personnel.
B. HACCP Training and HACCP Resource Materials
1. Dairy Foods HACCP Core Curriculum Training

2. USDA / FDA HACCP Training Programs and Resources Database
IX. HAZARDS AND CONTROL GUIDE
These tables may be used by the milk plant HACCP team as a guide to the
identification of potential hazards that may be associated with the incoming raw
materials (Table 1) and the processing steps (Table 2) used by a typical dairy
processing plant.
This guide may, or may not, be relevant to the conditions found at a specific milk
plant.
Each milk plant HACCP team must determine, for itself, the relevance of the
potential hazards identified in the tables or other potential hazards, identified
independently by the milk plant HACCP Team or by experts the HACCP Team may
employ when developing its HACCP system.
The “Ingredient or Process” column presents typical steps used in milk processing. It
is not intended to be complete or accurate for any specific milk plant or to serve as a
template for describing process steps in specific milk plants.
The “Potential Hazard” column identifies some hazards that might be expected at
various processing steps. Additional hazards may exist in individual circumstances
and MUST be identified and considered in the hazard analysis.
The “Hazard Rationale” column provides the reasons why each hazard was listed in
the Hazard Identity column for a particular processing step.
The “Hazard Management Controls” column provides examples used to illustrate the
accepted level of public health protection that is likely to be found acceptable for
regulatory licensing and IMS listing. Any measure that can be demonstrated to
provide a similar level of public health protection, but is not listed in this Guide, is
also acceptable, as long as it meets the requirements of the NCIMS Dairy HACCP
Program and is consistent with relevant state and federal laws or regulations.
The “Additional Resources” column provides references to the following sources of

information: Key to Abbreviations and References Used in Tables 1 and 2
1. Pasteurized Milk Ordinance (PMO)
2. U. S. Code of Federal Regulations (CFR)
3. Interpretive Memoranda published by the FDA IMS List, M-a, M-b, and M-I
memoranda
4. IMS List Sanitation Compliance and Enforcement Ratings of Interstate Milk
Shippers (www.cfsan.fda.gov/~ear/ims-toc.html)
5. FDA Compliance Policy Guides (CPG)
6. 3-A Sanitary Standards (3-A SS) and 3-A Accepted Practices (3-A AP)
7. Dairy Practices Council (DPC) Guidelines. References are to specific
guideline identification numbers, “DPC 8”.
8. Good Agricultural Practices (GAPs)
9. Current Good Manufacturing Practices (cGMPs)
10. National Drug Residue Database (NMDRD) Report
TABLE 1 - MILK PLANT RAW MATERIALS
INGREDIENT POTENTIAL HAZARD RATIONALE HAZARD MANAGEMENT OR ADDITIONAL
OR PROCESS HAZARD CONTROLS RESOURCES
Raw Milk Biological -
B-1: B-1: Scientific studies have shown B-1: Minimize the incoming PMO Sec 4
Presence of that a wide range of pathogens bacterial load by purchasing Grade PMO Item 12p
vegetative (organisms which can cause illness in “A” IMS listed raw milk and testing IMS List
Pathogens humans) can be present in incoming product. Verify that tank PMO Item 17p
unpasteurized milk. 4, 5 trucks were cleaned and sanitized DPC 25
prior to picking up the milk being DPC 50
unloaded (wash tags or in the case
of trucks that only deliver to one
plant, plant cleaning records) and
that milk has been maintained at
the proper temperature.
Chemical -
C-1: C-1: This hazard must be addressed C-1: At a minimum, screen all M-a-75
Presence of based on “Other NCIMS tankers for animal drug residues as M-a-86
Therapeutic Requirements”. required by Appendix N or other PMO Appendix
Drugs regulatory mandates. In addition, N
plants are encouraged to screen DPC 22
for other residues as indicated by
available information.
C-2: C-2: Mold growth in animal feed can C-2: Aflatoxin has been shown to
Presence of contaminate milk with aflatoxin M1. be present in raw milk dependent
Mycotoxins on geographic locations, growing
season conditions and past history.
Other management controls may
include supplier guarantees and
COA’s.
Physical -
Page 32 of 64
P-1: P-1: If dairy cattle are not kept clean P-1: Not to be included in the
Extraneous or if milk is drawn in an unclean hazard analysis if purchasing milk
Material environment and is not properly from Grade “A” IMS listed sources
protected, physical objects from the to minimize the contamination.
farm environment may become
incorporated into the milk.
Pasteurized Biological -
milk, heat B-1: B-1: Heat-treated milk products may B-1: Heat-treated milk or cream IMS List
treated milk Presence of not have been heated sufficiently to should be treated as raw milk and PMO Sec 7
or cream, and vegetative deactivate these organisms. come from approved sources.
condensed Pathogens
skim milk B-2: B-2: Bulk shipped pasteurized milk B-1: Verify that tank trucks were PMO Items
Contaminatio products may have been subject to cleaned and sanitized prior to 12p, 17p, &
n by recontamination during transit. picking up the milk being unloaded 21p
vegetative (wash tags or in the case of trucks 3-A SS 605
pathogens that only deliver to one plant, plant
cleaning records) and that milk has
been maintained at the proper
temperature.
Chemical -
None
Physical -
None
Other Biological
Ingredients / B-1: B-1: Pathogens may be present in B-1: Supplier certificates of 21 CFR
Packaging Presence of ingredients.6, 7, 8 analysis. 110.80(a)
Materials vegetative
Pathogens
Chemical
Page 33 of 64
C-1: C-1: Adulteration with toxic or C-1: IMS Listed packaging 21 CFR
Presence of carcinogenic chemicals has been suppliers. 110.80(a)
toxic or documented.9, 10, 11 Supplier letter of guarantee. 21CFR
carcinogenic 176.260
substances 21CFR
178.010
Physical
P-1: P-1: Free of foreign materials which P-1: Supplier letter of guarantee. 21 CFR
Extraneous constitute food safety hazards.7, 12 110.80(a)
Material CPG 555.425
Page 34 of 64
TABLE 2 - MILK PLANT PROCESSING OPERATIONS
Receiving – Biological
Materials B-1: B-1: B-1: DPC 8
shipped by bulk Contaminatio The truck unloading area has the Truck unloading are should be PMO Item 5p(4)
tanker, e.g. fluid n with potential to contaminate liquid milk constructed to protect the milk (at & 15p(A)(3)
milk and milk vegetative products. These products are a minimum overhead protection 3-A SS 02-, 11-,
products pathogens normally transmitted through and concrete, or equivalent 28-,29-,53-, 58-,
equipment that if unclean, (or surface under the truck that is 59-, 62-, 63-,
uncleanable) can result in bacterial properly drained). Maintain the 74-
contamination. truck unloading area and
equipment clean. Protect the milk
that is being unloaded by closing
in the unloading area or using
filters over the vent /personnel
access port area. Using
equipment meeting sanitary
design guidelines.
Chemical
C-1: C-1: C-1: PMO Item
Cleaning & Without proper separation between Maintain proper separation or a 15p(B)(1)
Sanitizing cleaning & sanitizing solutions and physical break between circuits 3-A AP 605
Residues product there could be contamination containing cleaning solutions and 21CFR178.1010
of the product.9 vessels and lines used to contain (a)
or conduct product.
Physical
P-1: P-1: P-1: 3-A SS 10- & 42-
Extraneous Free of foreign material which Use a filter, screen or other PMO Item
Materials constitute food safety hazards.7, 12 appropriate device at some point 11p(8)
in the system.
Page 35 of 64
P-2: P-2: P-2: PMO Item 11p
Metal Equipment in poor repair or An effective preventive 3-A SS 10- & 42-
shavings, improperly assembled may maintenance program and routine
gasket contaminate product with foreign (daily) inspection of equipment for
material & material. wear or missing parts. Use of a
other foreign filter, screen or other appropriate
material from device at some point in the
receiving system.
equipment
Receiving – Biological
Materials B-1: B-1: B-1: DPC 8
shipped by Contaminatio Product may become contaminated if Inspect product during unloading 21CFR
common carrier, n with product containers are damaged operations for damage. 110.80(a)(2)
e.g. dry vegetative during shipment.
ingredients, pathogens
flavors and Chemical
packaging C-1: C-1: C-1: DPC 8
materials. Toxic Delivery trucks may have been used Inspect vehicles prior to unloading
Chemicals to transport toxic chemicals prior to for evidence of unsanitary
food products or packaging conditions, spilled chemicals, off
materials.9 odors, of evidence that might
indicate the delivered product
may have been contaminated.
Physical
P-1: P-1: P-1: DPC 8
Extraneous Vehicles may have not been Inspect vehicles prior to unloading
Materials maintained in good repair or have for evidence of foreign materials
been used to carry metal or wood that may have contaminated the
articles.12 product.
Biological
Page 36 of 64
Raw Milk B-1: B-1: B-1: PMO Item 12p
Storage Contaminatio These products are normally stored in Verify that storage vessels and 3-A SS 22- & 63-
n with vessels that, if unclean (or associated lines and valves similar 3-A AP 605-
vegetative uncleanable), can result in bacterial appurtenances are constructed in 21CFR
pathogens contamination. 9, 11 such a way that they can be 110.35(d)
cleaned. Maintain records storage PMO Item
vessels are cleaned after each 15p(A)(3)
use. Maintain records that the
associated lines, valves and
similar appurtenances are cleaned
as needed but at least each day
used. Pipeline openings (e.g., flow
control panels) and outlet valves
are capped when not in use, other
openings are closed with tight
fitting covers. Associated
pipelines and similar
appurtenances are similarly
protected.
Page 37 of 64
B-2 : B-2: B-2: PMO Item 17p
Growth of Without proper temperature and time Maintain the temperature PMO Item 12p
vegetative controls, vegetative pathogens can sufficiently low to minimize the 21CFR
pathogens multiply to levels that may be capable growth of pathogens. Clean the 110.35(d)
of overwhelming the pasteurization storage vessels and associated PMO Item 12p
process with out proper temperature lines and valves similar
and time controls.9, 11 appurtenances at frequencies that
do not allow for bacterial growth
of pathogens in the product at the
product temperature used. Note:
If times or temperatures less
stringent than specified in the
PMO are used, they must be
reviewed and found acceptable to
the State and FDA.
Chemical
Cleaning & Without proper separation between Maintain proper separation or 15p(B)
Solution product there could be product containing cleaning solution and 21CFR
Residues contamination.9 vessels and lines used to contain 178.1010(a)
product.
Physical
None
Biological
Page 38 of 64
Storage, B-1: B-1: B-1: DPC 8
Blending & Contaminatio Pathogens can be present in the Verify that blending equipment 3-A SS 32-, 63-,
Addition of n with environment in the dry blending area. and associated lines and valves & 73-
Ingredients vegetative Product is usually exposed during similar appurtenances are 21CFR
pathogens blending. Ingredients may become constructed in such a way that 110.35(d)
contaminated by equipment that is they can be cleaned. Maintain 3-A AP 605-
unclean or uncleanable.9 records that they are cleaned as PMO Item 9p(3)
needed but at least each day & 9p(4)
used. Maintain the addition /
blending environment clean and
relatively free of dust or soil that
could contaminate product during
addition / blending. Equipment
used for addition / blending is
constructed to minimize product
or ingredient exposure.
Chemical
product.
Page 39 of 64
C-2: C-2: C-2: FDA CPG
Allergens Foods which contain undeclared Documented PP’s or other 555.250
being mixed allergens may cause life threatening effective practices and programs
with products reactions in sensitive individuals. must be in place and monitored in
that are not such a way that will assure
labeled as allergen containing ingredients
containing (other than milk and milk
allergens products) are used only in Grade A
milk and milk products that are
properly labeled as containing
those allergens in the ingredients.
These documented and monitored
programs need, at a minimum to
include requirements and
procedures to assure:
♦ Separation and identification
of such allergens during
storage.
♦ Addition only of those products
that are properly labeled must
be monitored and
documented.
♦ Equipment that is used for
storage, blending or addition
of both ingredients that do not,
must be thoroughly cleaned
after the equipment has been
used for allergen containing
ingredients for foods which do
not declare that allergen.
♦ If plant programs other than
PP’s or CCP’s are used, those
records needed to ensure
allergens are adequately
Page 40 of 64
Physical
P-1: P-1: P-1: DPC 8
Extraneous Inadvertent addition of packaging Opening of ingredients is 3-A SS 10- & 42-
Materials material and other objects which are conducted in a manner that will PMO Item 9p(3)
present in the blending area. minimize the opportunity for bits & 9p(4)
of packaging, cutting tools, etc.
from entering the product.
Verification that, at some point in
the process ingredient or the milk
product to which the ingredient is
added, will pass through a filter,
screen, small orifice (such as
occurs during homogenization or
other appropriate device.
Biological
Separation B-1: B-1: B-1: DPC 8
Contaminatio If this equipment is unclean or Verify that the separation 3-A AP 605-
n with uncleanable, it can contaminate equipment and associated lines 21CFR
vegetative products that pass through it.12 and valves and similar 178.1010(a)
pathogens appurtenances are constructed in
such a way that they can be
cleaned. Maintain records that
the equipment is cleaned after
each day used.
Chemical
None
Physical
None
Biological
Page 41 of 64
Skim and / or B-1: B-1: B-1: 3-A AP 605-
Cream Cold Vegetative pathogens can multiply to Maintain the temperature 3-A SS 22- & 63-
Cooling and separated or levels that may be capable of sufficiently low to minimize the
Storage heat treated overwhelming a pasteurization growth of pathogens. Clean the
skim or process.11 storage vessels and associated
cream can lines and valves and similar
have appurtenances at frequencies that
vegetative do not allow for bacterial growth
pathogens of pathogens in the product at the
PMO are to be used, they must be
the State and FDA.
Chemical
product.
Physical
None
Pasteurization Biological
Page 42 of 64
B-1: B-1: B-1: PMO Items 12p,
Survival of Minimum pasteurization times and Under NCIMS Dairy HACCP 15p(B), 16p and
vegetative temperatures have been well program, pasteurization and the Appendices H &
pathogens documented and are required for the design, construction and operation I
elimination of pathogens normally and testing of pasteurization 3-A AP 603-
present in unpasteurized milk. 9, 11, 13, 14 equipment must conform to all of 3-A AP 605-
the requirements of the Grade A
Pasteurized Milk Ordinance. Note:
If cleaning frequencies are to be
performed at frequencies less
than those specified in PMO Item
12p, the cleaning frequencies are
to be reviewed and found
acceptable to the State and FDA.
B-2: B-2: B-2: PMO Item 16p
Contaminatio Pasteurizer regenerator sections have Under NCIMS Dairy HACCP 3-A AP 603-
n with been documented to occasionally program, pasteurization and the 3-A AP 605-
vegetative leak. Raw and pasteurized milk are design, construction and operation
pathogens on opposite sides of a metal barrier and testing of pasteurization
(plate or tubular) in these regenerator equipment must conform to all of
sections. 11 the requirements of the Grade A
Pasteurized Milk Ordinance.
Chemical
Page 43 of 64
product. Particular attention is
needed to assure that the
required separation remains in
place during partial washes,
sometimes called “short washes”
or “ inter-washes” that may be
done during an operating day.
C-2: C-2: C-2: 3-A 603-
Allergens Foods which contain undeclared Pasteurization equipment and 3-A 605-
being mixed allergens may cause life threatening associated piping and valves that FDA CPG
with products reactions in sensitive individuals. are used for both Grade "A" milk 555.250
that are not and milk products foods that do
labeled as not, must be thoroughly cleaned
containing after use for allergen containing
allergens foods before it is used for foods
that do not declare that allergen.
C-3: C-3: C-3: 21CFR 173.310
Boiler Some boiler water compounds used in If indicated by the hazard analysis,
Additives the production of steam to be used in boiler water additives may be
contact with food or food contact managed by PP #1 – Safety of
surfaces may contain toxic Water. Compliance to 21CFR
substances. 173.310 may be verified by a
letter of guarantee from the
chemical supplier.
Page 44 of 64
C-4: C-4: C-4:
Cooling water Some cooling water / media additives Cooling water additives that are
/ Media that may come in contact with food or non-toxic under the condition of
Additives food contact surfaces may contain use should be used and their
toxic substances. safety verified by a letter of
guarantee form the chemical
supplier.
Physical
None
Pasteurized Biological
Milk & Milk B-1: B-1: B-1: 3-A AP 605
Product Contaminatio Human illness outbreaks have been Openings and outlet valves are 3-A SS 22- & 63-
Storage n with linked to post-pasteurization capped when not in use, other
(Except dry vegetative contamination of milk and milk openings are closed with tight
products) pathogens products.11, 15, 16, 17 fitting covers. Associated
pipelines and similar
appurtenances are similarly
protected.
Verify that storage vessels and
associated lines and valves and
similar appurtenances are
constructed in such a way they
can be cleaned. Maintain records
storage vessels are cleaned after
each use. Maintain records that
used.
Page 45 of 64
B-2: B-2: B-2: 3-A AP 605
Growth of Human illness outbreaks have been Maintain the temperature
Vegetative linked to post-pasteurization sufficiently low to minimize the
Pathogens contamination of milk and milk growth of pathogens. Clean the
products.11, 15, 16, 17 storage vessels and associated
lines and valves and similar
appurtenances at frequencies that
the State and FDA.
Chemical
Sanitizing cleaning & sanitizing solutions and physical break between circuits 21CFR
Solution product there could be product containing cleaning solution and 178.1010(a)
Residues contamination.9 vessels and lines used to contain
product.
Physical
None
Biological
Page 46 of 64
Pasteurized B-1: B-1: B-1: IMS List
Milk and Milk Contaminatio Human illness outbreaks have been Packaging may come from an IMS 3-A SS 17- & 23-
Product – n with linked to post-pasteurization listed source with associated 21CFR
Packaging vegetative contamination of milk and milk letters of guarantee, or the milk 178.1010
(Except Dry pathogens products.9 plant may perform tests to verify
Products) the ongoing safety of the
packaging.
After receipt, single service
containers and other single
service items must be protected
from recontamination.
Filling equipment and
appurtenances must be cleanable
and inspectable and must be
constructed and operated to
protect the product being
packaged from contamination.
Acceptable criteria for such
construction can be found from
such sources as the PMO and 3A
Sanitary Standards and Practices.
Chemical
product.
Page 47 of 64
C-2: C-2: C-2: CFR
Toxic or Packaging material that does not Packaging material or components IMS List
Carcinogenic meet CFR requirements may contain comes from a sourced from
substances in non-food grade substances.18 suppliers to be free of certain
the toxic or carcinogenic substances.
packaging One way to do this is to use
packaging from IMS listed sources
C-3: C-3: C-3: FDA CPG
Allergens Foods that contain undeclared Packaging machinery and 555.250
being mixed allergens may cause life threatening associated piping and valves that
with products reactions in sensitive individuals. are used for both Grade A milk
that are not and milk products foods that
labeled as contain allergens (other than milk)
containing and Grade A milk and milk
allergens products that do not, must be
thoroughly cleaned after use for
allergen containing foods before it
is used for foods that do not
declare that allergen.
Physical
P-1: P-1: P-1:
Glass Glass fragments may be present in Maintain a glass free zone.
processors packaging in glass.
Packaged Milk Biological
Product B-1: B-1: B-1:
Storage Contaminatio Condensate which drips on the Product needs to be stored away
(Except Dry n with pouring lip of the container may from areas where condensate
Products) vegetative contaminate the pouring lip of the could drip on the container.
pathogens container with pathogens.
Page 48 of 64
B-2: B-2: B-2:
Growth of Lack of temperature control in coolers Thermometers need to be located
Pathogens may result in growth of pathogens if in the warmest sections of product
present in the product.19 coolers and monitored to be sure
that the coolers will hold product
below the bacterial growth range.
Temperature meets the NCIMS
requirements.
Chemical
None
Physical
None
Bulk Biological
Pasteurized B-1: B-1: B-1: 3-A AP 605-
Product – Load Contaminatio Pathogens have been found in bulk Load out product “fitting to fitting” PMO Section 4
Out (Except n with pasteurized product either from the with the truck openings closed or 3-A SS 02- & 62-
Dry Products) vegetative load out process or from loading into otherwise adequately protected.
pathogens tankers which have not been cleaned Use and properly maintain a
and sanitized.9, 11 system of lies and valves for load
out that is separate from that
used to receive products for
pasteurization or repasteurization.
Tank trucks must not be used to
haul contaminating substances
such as unpasteurized liquid eggs
without a through cleaning and a
detailed inspection. Verify that
the trucks were clean and
sanitized prior to loading (wash
tags or in the case of trucks that
only deliver to one plant, plant
cleaning records).
Chemical
Page 49 of 64
product.
Physical
None
Starter Media Biological
Preparation, B-1: B-1: B-1, B-2: PMO Item 16p
Starter Media Contaminatio Starter media and culture is added to Starter media is pasteurized as 3-A AP 603-
Culturing and n with product post-pasteurization. required in the PMO prior to 3-A SS 25-
Product vegetative culturing and is protected during
Culturing pathogens culturing of the media and during
Page 50 of 64
B-2: B-2: addition to the product to be 3-A SS 02-, 25-,
Growth of Dairy products are cultured under cultured. Dairy products being & 38-
Pathogens conditions conductive to the growth cultured will be protected from 3-A AP 605-
of pathogens. contamination during set either by 3-A AP 604-
enclosing or covering the vats
during set or by controlling
environmental conditions around
the vats during set. Some
environmental controls would
include, positive air pressure in
the set room (the incoming air
must be filtered or otherwise
treated to prevent it from being a
source of bacterial
contamination). Pallets of
packaging or other potential
sources of contamination must not
be present during set. Packaging
or other operations that could be a
source of contamination must be
isolated from the vats being set.
A separate room for setting open
vats is preferred.
B-3 B-3: B-3:
Development Dairy products are cultured under The plant needs a procedure to
of Toxins conditions that may allow toxin- handle “Slow” vats that will
producing bacteria to grow and eliminate the possibility that
produce toxins in the case of starter cultured products containing
culture failure or partial failure. toxins sold or distributed as food.
Chemical
Page 51 of 64
product. If curd wash water is
treated with a disinfectant, the
levels shall be controlled to
prevent adulteration.
Physical
P-1: P-1: P-1: 3-A SS 24- & 25-
Extraneous Market withdrawals and recalls have Openings on the starter media
Material occurred for foreign materials in dairy and cultured products vessels and
products.12 associated equipment are kept
closed. All product–handling
equipment is properly designed
and maintained in good repair.
Milk or Milk Biological
Product –
Direct Set
None
Chemical
product.
Physical
P-1: P-1: P-1: 3-A SS 24- & 25-
Page 52 of 64
Ingredient / Biological
Flavoring B-1: B-1: B-1:
other than dry Contaminatio Ingredient / flavorings are added post Ingredients to be added after
– Added Post n with pasteurization. pasteurization are verified /
Pasteurization vegetative certified to be sterilized and
pathogens hermetically sealed, incapable of
supporting bacterial growth (salt
and some alcohol based flavors,
etc.) or otherwise rendered
incapable of carrying pathogens
into the product. Use of fresh fruit
having a pH of 4.7 or less, or
ingredients having a water activity
of 0.85 or less, or a high acid
content product or roasted nuts,
or flavoring extracts having high
alcohol content as part of a plant
quality assurance programs to
assure that these ingredients do
not contaminate the dairy
product.
Chemical
C-1: C-1: C-1:
Contaminates Ingredients may contain unintended Supplier guarantees obtained for
in the contaminates. all post pasteurization added
Ingredient ingredients.
Page 53 of 64
C-2: C-2: C-2: 3-A SS 02-, 32-,
Allergens Foods that contain undeclared Ingredient addition equipment 35-, 51-, 52-,
being mixed allergens may cause life threatening such as hoppers and feeders and 63-, 68-, 73-,
with products reactions in sensitive individuals. associated piping and valves that 81-
that are not are used for milk and milk FDA CPG
labeled as products that contain allergens 555.250
containing (other than milk) and milk and
allergens milk products that do not , must
be thoroughly cleaned after use
for allergens before it is used for
foods that do not declare that
allergen.
Physical
P-1: P-1: P-1: 3-A SS 24- & 25-
Biological
Page 54 of 64
Whey – B-1: B-1: B-1: 3-A SS 01-, 02-,
Handling and Contaminatio Pathogens may be introduced during Verify that storage vessels and 22-, 25-, 32-,
Storage n with whey handling and storage. associated lines and valves and 57-
vegetative similar appurtenances are 3-A AP 605-
pathogens constructed in such a way they
can be cleaned. Maintain records
storage vessels are cleaned after
each use. Maintain records that
used.
B-2: B-2: B-2:
Growth of Pathogens, if present, may grow Condensed products (including
Pathogens during storage. foam and splash) are not held in
bacteria growth range.
Maintain the temperature
sufficiently low to minimize the
growth of pathogens. Clean the
storage vessels and associated
lines and valves and similar
appurtenances at frequencies that
the State and FDA.
Chemical
Page 55 of 64
product.
Physical
None
Milk and Whey Biological
Product – B-1: B-1: B-1: 3-A AP 610
Membrane Contaminatio Pathogens may be introduced during Product balance bowl and other 3-A SS 26-
Filtration n with membrane filtration. openings into the system must be PMO Item 16p
vegetative kept tightly closed during 3-A A 603
pathogens processing.
Chemical
product.
Physical
None

Product - B-1: B-1: B-1: 3-A AP 607
Condensing Growth of Pathogens, if present, may grow Product to be condensed must be
Pathogens during storage.10 pasteurized prior to entering the
condenser.
Chemical
Page 56 of 64
product.
Physical
None
Whey Product Biological
Crystallization B-1: B-1: B-1:
Contaminatio Pathogens may be introduced during Openings into crystallization
n with crystallization. vessel are closed with tight fitting
vegetative covers.
pathogens
B-2: B-2: B-2:
Growth of Pathogens, if present, may grow The control limit is the maximum
Vegetative during the crystallization process. limit on the crystallization time.
Pathogens
Chemical
product.
Physical
None
Condensed Biological
Milk and Whey B-1: B-1: B-1:
Product Contaminatio Pathogens may be introduced during Outlet valves and other openings
Storage n by storage. into tanks are protected with tight
Pathogens fitting covers.
Page 57 of 64
B-2: B-2: B-2:
Growth of Pathogens, if present, may grow Condensed product (including
Pathogens during storage. foam and splash) are not held in
bacterial growth range.
Chemical
product.
Physical
None
Product - B-1: B-1: B-1: 3-A AP 607 &
Drying Contaminatio Cracks and crevices in dryers have Dryers need to be carefully 608
n by been found to contain Salmonella inspected and any cracks,
Pathogens capable of surviving in dry crevices or similar dead end areas
environment. 12 repaired or the dryer removed
from service.
Chemical
None
Physical
P-1: P-1: P-1: 3-A SS 24- & 25-
Extraneous Market withdrawals and recalls have Openings on the dryer and
Material occurred for foreign materials in dairy associated equipment are kept
products.12 closed. All product–handling
Product should pass through
screens to remove extraneous
materials.
Page 58 of 64
Packaged and Biological
Bulk Dry Milk B-1: B-1: B-1: T14
and Whey Contaminatio Salmonella has been found in Keep dry product storage areas, 3-A SS 34-
Products – n with environmental testing in dry product including overhead ledges and
Storage and Pathogens storage areas. 9, 12 beams as well as electrical boxes
Shipment such as and similar areas clean.
Salmonella Do not salvage damaged bags for
that can human food.
survive in dry Bags, bulk containers & totes in
environments storage areas are dust tight.
and products Bulk powder storage must be of
sanitary construction and
cleanable.
Chemical
None
Physical
None
Biological
Page 59 of 64
Aseptic B-1: B-1: B-1: PMO Section 5
Product - Contaminatio Botulism toxin is one of the most Under the NCIMS Dairy HACCP 21 CFR 108 &
Processing n by toxic substances that can be found in program, aseptic processing and 113
pathogens, food.15, 20, 21 the design, construction and PMO Items 12p,
such as C. operation and testing of aseptic 15p(B), 16p &
botulinium processing equipment must Appendices H &
conform to all of the requirements I
of the Grade “A” Pasteurized Milk PMO Item
Ordinance, 21CFR 108 and 113, 16p(D)
and the filed process for the
products being produced. Note: If
cleaning frequencies are to be
performed at frequencies less
than those specified in the PMO
Item 12p, they are to be reviewed
and found acceptable to the State
and FDA.
B-2: B-2: B-2: 21 CFR 108 &
Survival of Botulism toxin is one of the most Under the NCIMS Dairy HACCP 113
pathogens toxic substances that can be found in program, aseptic processing and PMO Item
such as C. food.15, 20, 21 the design, construction and 16p(C)
botulinium operation and testing of aseptic
processing equipment must
conform to all of the requirements
of the Grade “A” Pasteurized Milk
Ordinance, 21CFR 108 and 113,
and the filed process for the
products being produced.
Chemical
Page 60 of 64
product. Particular attention is
needed to assure that the
required separation remains in
place during partial washes,
sometimes called “short washes”
or “ inter-washes” that may be
done during an operating day.
Physical
None
Aseptically Biological
Processed B-1: B-1: B-1:
Product (bulk) Survival of Pathogens, if present, can grow Aseptic processing and the design,
- Storage pathogens during storage.15, 20, 21 construction and operation and
such as C. testing of aseptic processing
botulinium equipment must conform to all of
the requirements of the Grade “A”
Pasteurized Milk Ordinance, 21CFR
108 and 113, and the filed process
for the products being produced.
Note: If cleaning frequencies are
to be performed at frequencies
less than those specified in the
PMO Item 12p, they are to be
the State and FDA.
Chemical
Page 61 of 64
product.
C-2: C-2: C-2: IMS List
Toxic or Packaging material, which does not Packaging material comes from a 21CFR 110.80
carcinogenic meet CFR requirements, may contain source that has been verified to
substances in toxic or carcinogenic substances.18 be free of toxic or carcinogenic
the substances. One way to do this is
packaging to use packaging from IMS listed
sources.
Physical
None
Product lines Biological
and B-1: B-1: B-1: 3-A AP 605-
Equipment Contaminatio May introduce pathogens if unclean Verify that product lines and PMO Item 10p,
(General n by or uncleanable. equipment are constructed in such 11p, &12p
Concerns) Vegetative a way that they can be cleaned.
Pathogens Maintain records that storage
vessels are cleaned after each
use.
Maintain records that the product
lines and equipment cleaned as
needed nut at least each day
unless a longer interval has been
the State and FDA.
Chemical
Page 62 of 64
C-1: C-1: C-1: 3-A SS 02-, 32-,
Allergens Foods may contain undeclared Ingredient addition equipment 35-, 51-, 52-,
being mixed allergens may cause life threatening such as hoppers and feeders and 63-, 68-, 73-,
with products reactions in sensitive individuals. associated piping and valves that 81-
that are not are used for milk and milk FDA CPG
labeled as products that contain allergens 555.250
containing (other than milk) and milk and
allergens milk products that do not , must
be thoroughly cleaned after use
for allergens before it is used for
foods that do not declare that
allergen.
Physical
P-1: P-1: P-1: 3-A SS 10- & 42-
Extraneous Maintain equipment in good repair.12 Foreign materials that may have
Materials contaminated the product.
Use of water Biological
reclaimed B-1: B-1: B-1: PMO Appendix
from Contaminatio Water used in contact with product Properly implemented mandatory D – IV
condensing or n by & and product contact surfaces must be PP #1 - Safety of Water may PMO Appendix K
membrane growth of free of pathogens. reduce the likelihood of the
processing of pathogen occurrence of pathogens.
milk or whey Chemical
Products None
Physical
None
Direct Biological
Addition of None
Steam Chemical
Page 63 of 64
C-1: C-1: C-1: 3-A AP 609
Toxic Some boiler water compounds used in Supplier guarantees that boiler PMO Appendix
Substances the production of steam may contain water additives comply with H(III)
toxic substances. 21CFR 173.310 and PMO 21CFR 173.310
requirements for culinary steam.
Physical
None
Air Under Biological
Pressure B-1: B-1: B-1: PMO Appendix
(Incorporated Contaminatio Pathogens may be introduced in the Air is drawn from a clean area, is H (II)
into product or n by air supply. filtered at the intake as needed, PMO Item
directed at a Pathogens and is provided to the point of use 15p(A)(4)
food contact oil free and with free of excess DPC 8
surface.) moisture. A final filter is provided
as near as possible to the point of
use to verify these aspects.
Chemical
C-1: C-1: C-1: 3-A AP 604
Toxic Air compressor lubricants may be Air is drawn from a clean area, is 21CFR
Substances carried over into air and may be toxic. filtered at the intake as needed, 110.40(g)
and is provided to the point of use
oil free and with free of excess
moisture. A final filter is provided
as near as possible to the point of
use to verify these aspects.
Physical
None
Addition of Biological
reworked or
reclaimed
product
B-1: B-1: B-1: PMO 15p(A)(2),
Page 64 of 64
Contaminatio Reclaimed or reworked product may Product, which has not been 15p(B)(4), 5p(3)
n by have been handled in such a way to continuously in control of the & 18p(3)
Pathogens subject it to contamination with plant, to be reclaimed or reworked 21CFR
pathogens. is assumed to contain pathogens. 110.80(a)
When product is no longer under DPC 8
the control of the plant, it can not DPC 63
be assumed to have been held to
preclude temperature abuse or
adulteration. Only product that
has not left the control of the
plant should be used, kept
segregated, handled, protected
and cooled as appropriate for the
product with the exception of
product approved by the
regulatory agency.
Reworking is done in a clean area
and in a manner that will not
contaminate the product being
salvaged.
Chemical
C-1: C-1: C-1: 21CFR
Allergens Foods may contain undeclared Rework foods containing allergens 110.80(a)(5)
being mixed allergens may cause life threatening “like into like”. 21CFR
with products reactions in sensitive individuals. 101.100(a)(3)
that are not FDA CPG
labeled as 555.250
containing
allergens
Physical
P-1: P-1: P-1: 3-A 10 & 42
Extraneous These can result in choking or other Opening of products is conducted
Materials physical harm to consumers.9, 12 in a manner that will minimize the
Page 65 of 64
opportunity for bits of packaging,
cutting tools, etc. from entering
the product. Verification that, at
some point in the process
ingredient or the milk product to
which the ingredient is added, will
pass through a filter, screen, small
orifice (such as occurs during
homogenization or other
appropriate device.
Page 66 of 64
OTHER USEFUL REFERENCES
Published Text
• Alzamora, S. M., M. S. Tapia, and A. López-Malo; Minimally Processed

Fruits and Vegetables; Aspen Publishers, Inc. (2000)
• Bergey’s Manual of Systematic Bacteriology, Volume 2; Williams &
Wilkins Publishers (1986)
• Cliver, D. O. (editor); Foodborne Diseases; Academic Press (1990)
• Defigueiredo, M. P. and D. F. Splittstoesser (editors); Food Microbiology-
Public Health & Spoilage Aspects; AVI Publishing Company (1976)
• Doyle, M. P., L. R. Beuchat, and J. M. Thomas (editors); Food Microbiology:
Fundamentals and Frontiers; ASM Press
• Downing, D. L.; A Complete Course in Canning, 13th edition (in 3 volumes);
CTI Publications, Inc. (1996)
• Hanlon, J. F.; Handbook of Package Engineering, 2ed edtion; Technomic
Publishing Co., Inc. (1992)
• Heldman, D. R. and R. W. Hartel; Principles of Food Processing; Chapman &
Hall (1997)
• Hobbs, B. C. and R. J. Gilbert; Food Poisoning & Food Hygiene, 4th edition;
Food & Nutrition Press (1978)
• IDF Bulletin No. 275; Bacillus cereus in Milk and Milk Products; 1992
• Imholte, T. J.; Engineering for Food Safety and Sanitation; Technical
Institute of Food Safety (1984)
• Jay, J. M.; Modern Food Microbiology, 4th edition; Chapman & Hall
publishers (1992)
• Lund, B. M., T. C. Baird-Parker, and G. W. Gould (editors); The
Microbiological Safety and Quality of Food, Volumes I and II; Aspen Publishers
(2000)
• Marshall, R. T. (editor); Standard Methods For The Examination Of Dairy
Products, 16th edition; American Public Health Association (1992)
• Oliveira, F. A. R. and J. C. Oliveira (editors); Processing Foods- Quality
Optimization and Process Assessment; CRC Press (1999)
• Ray, B.; Fundamental Food Microbiology; CRC Press (1996)
• Roberts, T. A., A. C. Baird-Parker, and R. B. Thompkin (editors);
Microorganisms in Foods 5- Characteristics of Microbial Pathogens;
International Commission on Microbiological Specifications for Foods, Blackie
Academic & Professional publishers (1996)
• Roberts, T. A., J. I. Pitt, J. Farkas, and F. H. Grau (editors); Microorganisms
in Foods 6- Microbial Ecology of Food Commodities; International Commission
on Microbiological Specifications for Foods, Blackie Academic & Professional
publishers (1998)
Page 67 of 64
• Robinson, R. K. and R. A. Wilbey; Cheesemaking Practice, 3rd edition;
Aspen Publishing (1998)
• Shapton, D. A. and N. F. Shapton (editors); Principles and Practices for the
Safe Processing of Food; Woodhead Publishing Limited (1998)
• Shibamoto T and L. F. Bjeldanes; Introduction to Food Toxicology;
Academic Press (1993)
• Silliker, J. H., R. P. Elliott, A. C. Baird-Parker, F. L. Bryan, J. H. B. Christian,
D. S. Clark, J. C. Olson, and T. A. Roberts (editors); Microbial Ecology of Foods
2- Food Commodities; International Commission on Microbiological
Specifications for Foods, Academic Press (1980)
• Silliker, J. H., R. P. Elliott, A. C. Baird-Parker, F. L. Bryan, J. H. B. Christian,
D. S. Clark, J. C. Olson, and T. A. Roberts (editors); Microbial Ecology of Foods
1- Factors Affecting Life and Death of Microorganisms; International
Commission on Microbiological Specifications for Foods, Academic Press
(1980)
• Spreer, E.; Milk and Milk Product Technology; Marcel Dekker, Inc. (1998)
• Vanderzant, C. and D. F. Splittstoesser (editors); Compendium of Methods
for the Microbiological Examination of Foods, 3rd edition; American Public
Health Association (1992)
• Vanderzant, C., D. F. Splittstoesser, and others (editors); An Evaluation of
the Role of Microbiological Criteria for Foods and Food Ingredients; National
Academy Press (1985)
Articles Published in Peer Reviewed Scientific Journals
• Ahmed, Moustafa, and Marth; Incidence of Bacillus

cereus in Milk and Some Milk Products; J Food Prot 1983 Feb;46(2):126-8
• Andrade, Bridgeman, and Zottola; Bacteriocidal
activity of sanitizers against Enterococcus faecium attached to stainless
steel as determined by plat count and impedance methods; J Food Prot
1998 Jul;61(7):833-8
• Arizcun, Vasseur, and Labadie; Effect of several
decontamination procedures on Listeria monocytogenes growing in
biofilms; J Food Prot 1998 Jun;61(6):731-4
• Assanta, Roy, and Montpetit; Adhesion of Aeromonas
hydrophila to water distribution system pipes after different contact times;
J Food Prot 1998 Oct;61(10):1321-9
• Austin and Bergeron; Development of Bacterial
Biofilms in Dairy Processing Lines; J Dairy Research 1995; 62:509-19
• Baker and Griffiths; A Research Note: Evidence for
Increased Thermostability of Bacillus cereus Enterotoxin in Milk; J Food
Prot 1995 Apr;58(4):443-5
• Berry and Foegeding; Cold Temperature Adaptation
and Growth of Microorganisms; J Food Prot 1997 Dec;60(12):1583-94
• Bouman, Lund, Driessen, and Schmidt; Growth of
Thermoresistant Streptococci and Disposition of Milk Constituents on
Page 68 of 64
Plates of Heat Exchangers During Long Operating Times; J Food Prot 1982
Sep;45(9):806-12
• Bradshaw, Peeler, Corwin, Hunt and Twedt; Thermal
Resistance of Listeria monocytogenes in Dairy Products; J Food Prot 1987
Jul;50(7):543-4
• Buchanan, Damert, Whiting, and Schothorst; Use of
Epidemiologic and Food Survey Data to Estimate a Purposefully
Conservative Dose-Response Relationship for Listeria monocytogenes
Levels and Incidence of Listeriosis; J Food Prot 1997 Aug;60(8):918-22
• Budu-Amoako, Toora, Ablett and Smith; A Research
Note: Competitive Growth of Listeria monocytogenes and Yersinia
enterocolitica in Milk; J Food Prot 1993 Jun;56(6):528-32
• Bunning, Crawford, Tierney and Peeler;
Thermotolerance of heat-shocked Listeria monocytogenes in milk exposed
to high temperature, short-time pasteurization; Appl Environ Microbial
1992 Jun;58(6):2096-8
• Bunning, Crawford, Tierney, and Peeler;
Thermotolerance of Listeria monocytogenes and Salmonella typhimurium
after sublethal heat shock; Appl Environ Microbial 1990 Oct;56(10);3216-9
• Buncic and Avery; Relationship between variations in
pathogenicity and lag phase at 37 degrees C of Listeria monocytogenes
previously stored at 4 degrees C; Lett Appl Microbial 1996 Jul;23(1):18-22
• Butzler and Oosterom; Campylobacter: pathogenicity
and significance in foods; Int J Food Microbiol 1991 Jan;12(1):1-8
• Collins; Mycobacterium paratuberculosis: a potential
food-borne pathogen?; J Dairy Sci 1997 Dec;80(12):3445-8
• Cotton and White; Listeria monocytogenes, Yersinia
enterocolitica, and Salmonella in dairy plant environments; J Dairy Sci
1992 Jan;75(1):51-7
• Crawford, Beliveau, Peeler, Donnelly, and Bunning;
Comparative recovery of uninjured and heat-injured Listeria
monocytogenes cells from bovine milk; Appl Environ Microbiol 1989
Jun;55(6):1490-
• D’Aoust, Park, Szabo, Todd, Emmons, and McKellar;
Thermal inactivation of Campylobacter species, Yersinia enterocolitica,
and hemorrhagic Escherichia coli O157:H7 in fluid milk; J Dairy Sci 1988
Dec;71(12):3230-6
• Doyle and Roman; Prevalence and survival of
Campylobacter jejuni in unpasteurized milk; Appl Environ Microbiol 1982
Nov;44(5):1154-8
• Evenson, Hinds, Bernstein, and Bergdoll; Estimation
of human dose of staphylococcal enterotoxin A from a large outbreak of
staphylococcal food poisoning involving chocolate milk; Int J Food Mictobiol
1988 Dec 31;7(4):311-6
• Fernandez et al; Listeria monocytogenes in
pasteurized milk; Can J Microbiol 1986 Feb;32(2):149-50
• Fleming et al; Pasteurized milk as a vehicle of
infection in an outbreak of listeriosis; N Engl J Med 1985 Feb;312(7):404-7
• Fonden, Fitger, and Pettersson; Salmonella bacteria
in double cream; Nord Vet Med 1976 Jul-Aug;28(7-8):385-9
Page 69 of 64
• Francis, Spaulding, and Lovett; Enterotoxin
production and thermal resistance of Yersinia enterocolitica in milk; Appl
Environ Microbiol 1980 Jul;40(1):174-6
• Gomez-Lucia et al; Production of enterotoxin A by
supposedly non-enterotoxigenic Staphylococcus aureus strains; Appl
Environ Microbiol 1989 Jun;55(6):1447-51
• Gruetzmacher and Bradley; Identification and control
of processing variables that affect the quality and safety of fluid milk; J
Food Prot 1999 Jun;62(6):625-31
• Grant, Ball, and Rowe; Effect of high-temperature,
short-time (HTST) pasteurization on milk containing low numbers of
Mycobacterium paratuberculosis; Lett Appl Microbiol 1998 Feb;26(2):166-
70
• Grant, Ball, and Rowe; Effect of higher pasteurization
temperatures, and longer holding times at 72 degrees C, on the
inactivation of Mycobacterium paratuberculosis in milk; Lett Appl Microbiol
1999 Jun;28(6):461-5
• Grant, Ball, Neill, and Rowe; Inactivation of
Mycobacterium paratuberculosis in cows’ milk at pasteurization
temperatures; Appl Environ Microbiol 1996 Feb;62(2):631-6
• Greenwood, Hooper, and Rodhouse; The source of
Yersinia spp. in pasteurized milk: an investigation at a dairy; Epidemiol
Infect 1990 Jun;104(3):351-60
• Gruetzmacher and Bradley; Identification and Control
of Processing Variables That Affect the Quality and Safety of Fluid Milk; J
Food Prot 1999 Jun;62(6):625-31
• Harp, Fayer, Pesch, and Jackson; Effect of
pasteurization on infectivity of Cryptosporidium parvum oocysts in water
and milk; Appl Environ Microbiol 1996 Aug;62(8):2866-8
• Helke and Wong; Survival and Growth Characteristics
of Listeria monocytogenes and Salmonella typhimurium on Stainless Steel
and Buna-N Rubber; J Food Prot 1994 Nov;57(11):963-8
• Helke, Sommers and Wong; Attachment of Listeria
monocytogenes and Salmonella typhimurium to Stainless Steel and Buna-
N in the Presence of Milk and Individual Milk Components; J Food Prot 1993
Jun;56(6):479-84
• Holick, M. F., Q. Shao, W. W. Liu, and T. C. Chen; The
Vitamin D Content of Fortified Milk and Infant Formula; New England
Journal of Medicine 1992 Apr;326(18): 1178-1181
• Hood and Zottola; Growth Media and Surface
Conditioning Influence the Adherence of Pseudomonas fragi, Salmonella
typhimurium, and Listeria monocytogenes Cells to Stainless Steel; J Food
Prot 1997 Sep;60(9):1034-7
• Jacobus, C. H., M. F. Holick, Q. Shao, T. C. Chen, I. A.
Holm, J. M. Kolodny, G. E. Fuleihan, and E. W. Seely; Hypervitaminosis D
Associated With Drinking Milk; New England Luornal of Medicine 1992
Apr;326(18):1173-1177
• Jacquet, Rocourt, and Reynaud; Study of Listeria
monocytogenes contamination in a dairy plant and characterization of the
strains isolated; Int J Food Microbiol 1993 Oct;20(1):13-22
Page 70 of 64
• Junttila, Niemela and Hirn; Minimum growth
temperatures of Listeria monocytogenes and non-haemolytic Listeria; J
Appl Bacteriol, 1988 Oct;65(4):321-7
• Keswani and Frank; Thermal Inactivation of
Mycobacterium paratuberculosis in Milk; J Food Prot 1998 Aug;61(8):974-8
• Kim and Frank; Effect of Nutrients on Biofilm
Formation by Listeria monocytogenes on Stainless Steel; J Food Prot 1995
Jan;58(1):24-8
• Knabel, Walker, Hartman and Mendonca; Effects of
growth temperature and strictly anaerobic recovery on the survival of
Listeria monocytogenes during pasteurization; Appl Environ Microbiol,
1990 Feb;56(2):370-6
• Krysinski, Brown and Marchisello; Effect of Cleaners
and Sanitizers on Listeria monocytogenes Attached to Product Contact
Surfaces; J Food Prot 1992 Apr;55(4):246-51
• Lin, Schraft, Odumeru, and Griffiths; Identification of
contamination sources of Bacillus cereus in pasteurized milk; Int J Food
Microbiol 1998 Sep 8;43(3):159-71
• Lou and Yousef; Resistance of Listeria
monocytogenes to Heat after Adaptation to Environmental Stresses; J Food
Prot, 465-71, Vol. 59(5), 1996
• Lovett, Wesley, Vandermaaten, Bradshaw, Francis,
Crawford, Donnelly, and Messer; High-Temperature, Short-Time
Pasteurization Inactivates Listeria monocytogenes; J Food Prot, 734-8, Vol.
53(9), 1990
• Lovett, Bradshaw, and Peeler; Thermal inactivation
of Yersinia enterocolitica in milk; Appl Environ Microbiol 1982
Aug;44(2):517-9
• Mackey, Boogard, Hayes and Baranyi; Recovery of
heat-injured Listeria monocytogenes; Int J Food Microbiol, 1994
Jun;22(4):227-37
• Olsvik and Kapperud; Enterotoxin production in milk
at 22 and 4 degrees C by Escherichia coli and Yersinia enterocolitica; Appl
Environ Microbiol 1982 May;43(5):997-1000
• Pagan, Condon, and Sala; Effects of several factors
on the heat-shock-induced thermotolerance of Listeria monocytogenes;
Appl Environ Microbiol 1997 Aug;63(8):3225-32
• Palumbo, Call, Schultz, and Williams; Minimum and
Maximum Temperatures for Growth and Verotoxin Production by
Hemorrhagic Strains of Escherichia coli; J Food Prot, 352-6, Vol. 58(4),
1995
• Patchett, Watson, Fernandez, and Kroll; The effect of
temperature and growth rate on the susceptibility of Listeria
monocytogenes to environmental stress conditions; Lett Appl Microbiol
1996 Feb;22(2):121-4
• Pearson and Marth; Listeria monocytogenes threat to
a safe food supply: a review; J Dairy Sci 1990 Apr;73(4):912-28
• Pritchard, Beliveau, Flanders, and Donnelly;
Environmental Surveillance of Dairy Processing Plants for the Presence of
Yersinia Species; J Food Prot, 395-7, Vol. 58(4), 1995
Page 71 of 64
• Pritchard, Flanders, and Donnelly; Comparison of the
incidence of Listeria on equipment versus environmental sites within dairy
processing plants; Int J Food Microbiol 1995 Aug;26(3):375-84
• Radmore, Holzapfel, and Luck; Proposed guidelines
for maximum acceptable air-borne microorganism levels in dairy
processing and packaging plants; Int J Food Microbiol 1988 Feb;6(1):91-5
• Rajkowski, Calderone, and Jones; Effect of
polyphosphate and sodium chloride on the growth of Listeria
monocytogenes and Staphylococcus aureus in ultra-high temperature
milk; J Dairy Sci 1994 Jun;77(6):1503-8
• Rushing, J. E. and D. P. Wesen; Preventing Antibiotic
Residues in Milk; Department of Food Science, North Carolina State
University (FSE 99-21)
• Schiemann; Yersinia enterocolitica in milk and dairy
products; J Dairy Sci 1987 Feb;70(2):383-91
• Skirrow; Epidemiology of Campylobacter eneritis; Int
J Food Microbiol 1991 Jan;12(1):9-16
• Smoot and Pierson; Effect of environmental stress on
ability of Listeria monocytogenes Scott A to attach to food contact
surfaces; J Food Prot 1998 Oct;61(10):1293-8
• Smoot and Pierson; Influence of Environmental
Stress on the Kenetics and Strength of Attachment of Listeria
monocytogenes Scott A to Buna-N Rubber and Stainless Steel; J Food Prot,
1286-1292, Vol. 61, No. 10 (1998)
• Soudah and Boor; Persistence of Escherichia coli
O157:H7 in Dairy Fermentation Systems; J Food Prot, 1602-8, Vol. 61(12),
1998
• Sung and Collins; Thermal tolerance of
Mycobacterium paratuberculosis; Appl Environ Microbiol 1998
Mar;64(3):999-1005
• Wang, Zhao, and Doyle; Survival and Growth of
Escherichia coli O157:H7 in Unpasteurized and Pasteurized Milk; J Food
Prot, 610-3, Vol. 60(6), 1997
• Williams and Ingham; Changes in Heat Resistance of
Escherichia coli O157:H7 Following Heat Shock; J Food Protection, 1128-
1131, Vol. 60, No. 9 (1997)
• Wong; Biofilms in Food Processing Environments; J
Dairy Science, 2765-2770, Vol. 81, No. 10 (1998)
• Wong, Chang, and Fan; Incidence and
characterization of Bacillus cereus isolates contaminating dairy products;
Appl Environ Microbiol 1988 Mar;54(3):699-702
• Wong and Cerf; Biofilms: Implications for Hygiene
Monitoring of Dairy Plant Surfaces; IDF Bulletin 302 (1995)
• Zottola; Scientific Status Summary: Microbial
Attachment and Biofilm Formation- A New Problem for the Food Industry?;
Food Tech, 107-14, Vol. 48(7), 1994
Endnotes
Page 72 of 64
1
IFT, 2001. Evaluation and Definition of Potentially Hazardous Foods. Report for IFT/FDA Contract No. 223-98-2333, Task
Order No. 4. Chapter 6, Microbiological Challenge Testing.
2
Cliver, D. O.; Virus Transmission via Food; Institute of Food Technologists’ (1997)
3
Jacobus, C. H. , M. F. Holick, Q. Shao, T. C. Chen, I. A. Holm, J. M. Kolodny, G. E. Fuleihan, and E. W. Seely;
Hypervitaminosis D Associated With Drinking Milk; New England Journal of Medicine 1992 Apr; (18):1173-1177
4
Robinson, R. K. and R. A. Wilbey; Cheesemaking Practice, 3 rd edition; Aspen Publishing (1998)
5
Shibamoto T. and L. F. Bjeldanes; Introduction to Food Toxicology; Academic Press (1993)
6
Alzamora, S. M., M. S. Tapia, and A. Lopaz-Malo; Minimumally Processed Fruits and Vegetables; Aspen Publishers, Inc.
(2000)
7
Roberts, T. A., J. I. Pitt, J. Farkes, and F. H. Grau (editors); Microorganisms in Foods 6 – Microbial Ecology of Food
Commodies; International Commission on Microbiological Specifications for Foods, Blackie Academic & Professional
Publishers (1998)
8
Silliker, J. H., R. P. Elliott, A. C. Baird-Parker, F. L. Bryan, J. H. B. Christian, D. S. Clark, J. C. Olson, and T. A. Roberts
(editors); Microbial Ecology of Foods 2 – Food Commodities; International Commission on Microbiological Specifications for
Foods, Academic Press (1980)
9
Lund, B. M., T. C. Baird-Parker, and G. W. Gould (editors); The Microbiological Safety and Quality of Food, Volumes I and II;
Aspen Publishers (2000)
10
Spreer, E.; Milk and Milk Product Technology; Marcel Dekker, Inc. (1998)
11
Vanderzant, C. and D. F. Splittstoesser (editors); Compendium of Methods for the Microbiological Examination of Foods,
3 rd edition; American Public Health Association (1992)
12
Shaton, D. A., and N. F. Shapton (editors); Principles and Practices for the Safe Processing of Food; Woodhead Publishing
Limited (1998)
13
Heldman, D. R., and R. W. Hartel; Principles of Foods Processing; Chapman & Hall (1997)
14
Oliveria, F. A. R. and J. C. Oliveira (editors); PROCESSING Foods – Qualtiy Optimization and Process Assessment; CRC
Press (1999)
15
Cliver, D. O. (editor); Foodbourne Diseases; Academic Press (1990)
16
Defigueiredo, M. P. and D. F. Splittstoesser (editors); Food Microbiology – Public Health and Spoilage Aspects; AVI
Publishing Company (1976)
17
Jay, J. M.; Modern Food Microbiology, 4 th edition; Chapman & Hall Publishers (1997)
18
Hanlon, J. F.; Handbook of Package Engineering, 2 nd edition; Technomic Publishing Co., Inc. (1992)
19
Ray, B.: Fundamental Food Microbiology; CRC Press (1996)
20
Bergey’s Manual of Systematic Bacteriology, Volume 2; Williams & Wilkins Publishers (1986)
21
Roberts, T. A., A. C. Baird-Parker, and R. B. Thompkin (editors); Microorganisms in Foods 5 – Characteristics of
Microbiological Pathogens; International Commission on Microbiological Specifications for Foods, Blackie Academic &
Professional Publishers (1996)

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Hazards and

II. Terms and Definitions

III. Overview of the NCIMS HACCP Program

IV. Prerequisite Programs

VI. HACCP Decision Trees

VIII.Preparing for HACCP

IX. Hazards and Control Guide

This Hazards and Controls Guide represents the National Conference on

This Hazards and Controls Guide provides a framework for answering

HACCP, as it relates to the NCIMS HACCP alternative, is a food safety

The purpose of this guidance is to assist you in the development of a

To help understand some key aspects of the NCIMS Voluntary HACCP

C. Comparison with the FDA Juice HACCP Regulations

Requirements FDA Juice HACCP NCIMS HACCP

1/21/03 for Small

1/20/04 for Very Small

Prerequisite Program Yes Yes (PP)

Written Sanitation No Yes

Written Hazard Analysis Yes Yes

Written HACCP Plan Yes Yes

Written Corrective Yes Yes

HACCP Plan shall be Yes, Yes

Plan Revalidation Yes, at least once within Yes

At least annually Yes Yes

D. Scope and Limitations

This guide addresses development of a product flow diagram, description

A. AUDIT: An evaluation of the entire milk plant, receiving station or

B. Centralized Deviation Log: A centralized log or file identifying data

C. Control: To manage the conditions of an operation to maintain

D. Control Measure: Any action or activity that can be used to prevent,

E. Corrective Action: Procedures followed when a deviation occurs.

F. Critical Control Point (CCP): A step at which control can be applied

G. Critical Limit (CL): A maximum and/or minimum value to which a

H. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT,

I. DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:

J. DEFICIENCY: An element inadequate or missing from the

K. DEVIATION: A failure to meet a Critical Limit.

M. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A

N. HACCP PLAN: The written document, which is based upon the

O. HACCP SYSTEM: The implemented HACCP Plant and Prerequisite

P. HACCP TEAM: The group of people who are responsible for

Q. HAZARD: A biological, chemical, or physical agent that is reasonable

R. HAZARD ANALYSIS: The process of collecting and evaluating

S. MONITOR: To conduct a planned sequence of observations or

T. NON-CONFORMITY: A failure to meet specified requirements of the

U. POTENTIAL HAZARD: Any hazard to be evaluated by the hazard

V. PREREQUISITE PROGRAMS (PP’s): Procedures, including Good

W. VALIDATION: The element of verification focused on collecting and

A. Voluntary Nature of the Program

The NCIMS HACCP Program alternative to the traditional inspection system is

B. Key Requirements of the NCIMS HACCP Program

1. Specialized Training in NCIMS HACCP Principles Required

Regulatory Agency personnel responsible for the evaluation, licensing and

Industry, State and Federal regulatory and listing personnel should be

♦ Core Curriculum: The Dairy HACCP Core curriculum consists of:

The orientation component ideally is coupled with the basic HACCP

The industry individual(s) performing the functions listed in Part 2 of this

• Industry Personnel: Only industry individuals who have met the

a. Developing the hazard analysis, including delineating control

• Regulatory Personnel: Regulatory personnel performing HACCP audits

a. Required Records: It is essential that plants, receiving stations and

1. A brief description of the monitoring and correction records shall

2. A hazard analysis shall be written